Executive Summary

​Surgical staplers are complex devices requiring meticulous technique to operate. Some models are used just to staple (seal) tissue, while others are designed to both staple and cut. Consequences of a staple line failing or staples being misapplied can be fatal. Patients have experienced intraoperative hemorrhaging, tissue damage, unexpected postoperative bleeding, failed anastomoses, and other forms of harm.

Although the overall adverse event rate is actually quite low relative to how frequently staplers are used, problems associated with the use and function of surgical staplers are regularly reported. In fact, a recent FDA analysis covered over 100,000 incident reports since 2011, including 412 deaths, 11,181 serious injuries, and 98,404 malfunctions. Most of these reports had not previously been accessible to the public.   

In ECRI Institute's experience, adverse consequences can most often be traced to how the surgical stapler was used. That is, the device itself typically is found to have functioned as intended. Errors in use include selecting an incorrect staple size, clamping on tissue that is too thick or too thin, and clamping on, or firing over, another instrument or clip.

Avoiding such errors, as we detail in our recommendations, requires effective training and familiarity. Specifically, we recommend hands-on practice with the specific model of stapler to be used.

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Table of Contents

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Problem

1. Problems associated with the use and function of surgical staplers can lead to intraoperative hemorrhaging, tissue damage, unexpected postoperative bleeding, failed anastomoses, and other forms of patient harm.

a) ECRI Institute consistently receives reports of surgical stapler problems and has investigated many incidents in which patients were harmed, including some fatalities.

b) Further highlighting the risks, in 2019 FDA:

(1) Published an analysis of over 100,000 reports involving staples and internal surgical staplers since 2011. The vast majority of these reports had appeared only in FDA's Alternative Summary Reports (ASR) database, and thus had not previously been made accessible to the public.

(2) Proposed measures to reclassify internal surgical staplers as Class II devices, which are more tightly regulated than devices designated as Class I (the classification currently used for staplers).

c) Although the overall adverse event rate is actually quite low relative to how frequently staplers are used, severe injuries do occur: FDA's problem reporting data, along with ECRI Institute's own investigations, include fatalities and other incidents involving significant patient harm.

2. Common issues with the use of staplers include:

a) Misfiring or difficulty firing—this includes instances in which:

(1) Squeezing the stapler handle requires more force than usual

(2) Staples are not fully deployed after the device is fired

(3) The stapler does not articulate or rotate as intended

b) Misapplied staples—as can occur when:

(1) Staples of the wrong size are used

(2) Staples are applied to the wrong tissue

(3) The stapler is applied at an angle such that it does not fully reach across the structure

(4) The stapler is applied across a harder material (e.g., another previously deployed staple or a surgical instrument) that results in device damage and inappropriate staple formation

(5) Tissue in the stapler's jaws is distributed unevenly

c) Unusual sounds during firing. This can indicate a damaged or malfunctioning internal mechanism.

d) Failure to release tissue after firing—that is, tissue becoming "jammed" in the mechanism.

3. In most incidents that ECRI Institute has investigated, the stapler was found to have functioned as intended. Adverse consequences are most commonly related to how the device was used.

a) Staplers are complex devices requiring meticulous technique to operate; thus, device familiarity is key to safe use. (As we detail in the Background section, stapler designs can vary significantly from one brand to the next, even for devices that are intended for the same purpose.) Additionally, variations in patient tissue—not only from patient to patient, but also within the anatomical structures of any single patient—can present significant challenges for the surgeon.

b) Errors in application include selecting an incorrect staple size, clamping on tissue that is too thick or too thin, and clamping on, or firing over, another instrument or clip.

 

ECRI Institute Recommendations

Training

The chief of surgery and/or OR director should do the following:

1. Arrange hands-on device training for all members of the surgical team.

a) Training should be conducted by the manufacturer or by an experienced super-user at your facility.

b) Training should occur before surgeons use the stapler for the first time, or for the first time in a while.

c) Training should include:

(1) Knowledge of the available cartridge sizes and how to appropriately match those cartridges to patient tissue

(2) Cartridge installation, removal, and disposal

(3) Device articulation and rotation, if applicable

(4) Device firing sequence and knife retraction

(5) Knowledge of what can go wrong and how to respond when it does, including what to sequester in the case of potential third-party investigation

(6) Device disposal or reprocessing, as appropriate

2. Make provisions for clinicians to have effective hands-on practice time with surgical devices on sample tissue, before use of the devices during surgery is required.

Model-Specific Training

Surgeons and surgical staff should do the following:

1. Participate in training or hands-on practice (as outlined above) before using a stapler for the first time, or before using it for the first time in a while.

2. Read and follow the stapler manufacturer's instructions for use (IFU).

a) ECRI Institute acknowledges that the IFU for staplers might be easily overlooked. The instructions are often printed in very small font on folded inserts within the device packaging, and clinicians may be tempted to ignore the IFU if they assume they already know how to use a device.

b) Nevertheless, we believe that comprehension of the device IFU, in conjunction with manufacturer-provided training, will increase familiarity and comfort with the use of the device and reduce the incidence of adverse events.

3. Recognize that staplers from different manufacturers operate differently, and that experience with one model does not necessarily translate into skill with another model. Situations in which ECRI Institute would recommend training on a specific device include:

a) When a facility switches its endomechanicals contract from one manufacturer to another

b) When a clinician transitions to, or performs a procedure at a hospital that uses, a stapling device with which they are not familiar

c) When a model is recalled and replaced with a device from another manufacturer

4. Be aware of the intended use and potential contraindications (e.g., firing over an object such as a clip) of using these devices.

Before a Procedure

Surgeons and surgical staff should do the following:

1. Have an appropriate range of stapler cartridge sizes available for use.

a) Understand the array of possible staple sizes and their associated typical applications for a given stapler model. Then adjust the staple selection as the situation requires.

b) Keep in mind that tissue varies not only across patients but within the same patient, so there may be no single staple size that is suitable for all applications for a specific patient or patient tissue.

2. Have additional staplers and other means of closure available for immediate use.

a) Be prepared to switch staplers if a problem is identified with the original unit.

b) Alternative means of closure, such as manual sutures, should also be available.

3. Inspect the stapler for damage before using it. (Preferably, this should be done both by the scrub technician/nurse who opens the instrument pouch and by the surgeon who will use the instrument.)

a) Inspect the anvil and the cartridge to ensure proper alignment.

b) Verify that the shaft of the device is uniform and without any defects.

c) Verify that all the components of reusable staplers are present and that, when the device is assembled, the components are positioned properly and tightly fastened together.

d) In the case of reusable battery-powered staplers, make sure the device passes any designated self-tests for handle, adapter, and reload.

e) If the surgical stapler does not meet these criteria, use a different stapler.

During and After Use

Surgeons and surgical staff should do the following:

1. Do not use a stapler if you are unable to visually assess (either directly or with an endoscope) secure closure and hemostasis.

2. Before firing the stapler, pause to ensure that the staples are appropriately sized for the intended tissue. If you have difficulty squeezing the handle of the stapler, you may need to resize.

3. If the stapler makes unusual sounds or is difficult to fire during use:

a) Visually inspect the stapler either directly (during open procedures) or using an endoscope.

b) Check for excessive tissue, foreign material, or interference from another instrument and proceed with caution.

c) If sounds persist, continue the procedure with another stapler.

4. Adhere to the practices recommended by Fuller et al. (2014); specifically:

a) Avoid applying clips near an intended staple line site. Contact with objects in the stapler's path could damage the cartridge knife.

b) If a malfunction is noted when the stapler is closed on the tissue, "clamp or ligate the vessel before releasing the stapler."

c) If tissue is "jammed" in the stapler, avoid forcefully freeing the tissue; consider dissecting proximal to the stapler closure.

5. Once tissue has been stapled, check the application site for secure closure and hemostasis.

6. If you identify a faulty stapler:

a) In the absence of injury, return the stapler (with its device packaging if possible) to the supplier for analysis and credit.

b) If an injury has occurred, retain the following for possible third-party investigation (note that any items used on a patient should be appropriately labeled as "biohazardous" for shipping):

(1) The uncleaned stapler and all cartridges used. If possible, label cartridges according to the order in which they were used, and note which was the incident cartridge.

(2) Device packaging, showing the stapler and cartridge catalog and lot numbers

(3) Any loose or malformed staples found on used devices (e.g., the stapler anvil, used cartridges) or otherwise outside of the patient. These can be taped to a piece of paper to keep them from getting lost.

c) Contact ECRI Institute to report the problem.

Procurement

Materials management staff should do the following:

1. Communicate with clinicians during the device procurement process so that, when possible, surgeons can work with their preferred devices (Fuller et al. 2014). Lack of familiarity with a device can contribute to misuse and can increase the potential for patient harm.

2. To the extent possible, verify that the chosen stapling device meets the performance requirements specified by the clinicians who will be using it.

3. If a new model or manufacturer is selected for use in a facility, recognize that surgeons will need to be appropriately trained, as outlined above.

Incident Response

Administrators and other personnel should do the following:

1. Establish an investigation plan in the case of an adverse event.

2. Submit detailed reports of any incident to appropriate organizations—for example, to FDA (for U.S. healthcare facilities), as well as to ECRI Institute—and update those reports as new information becomes available.

a) Stapler problems are often reported simply as "stapler malfunction." While all reports are useful, those that are more descriptive have a much greater impact in improving patient safety. With the added detail, investigators can better understand the issues and thus develop more effective recommendations for addressing them.

b) Similarly, updating reports as new information is obtained can greatly improve the quality of problem reporting data. For example, an event that is initially classified as a malfunction without injury should be updated if an associated injury manifests days later.


 

Background

1. Surgical staplers are single-use or reusable devices intended for anastomosis and to seal and transect (staple and cut) tissues.

a) This report covers internal linear, circular, curved, cutter, and battery-powered surgical staplers.

b) Surgical applications include: GI tract, gynecological, pediatric, urologic, and thoracic surgeries.

c) Internal surgical stapler designs vary depending on whether the device is intended for open or endoscopic surgery, as well as whether it will be used just to staple tissue or to both staple and cut.

(1) Some cutting models, for example, first seal the tissue with lines of staples then transect those lines with a cutting mechanism to separate those parts of the anatomy.

(2) Using endoscopic linear cutter designs as an example: These staplers consist of a handle and a long, thin shaft with jaws at the end that can be closed on the tissue of interest. When the stapler is fired, rows of staples are deployed from the jaws into the clamped tissue on either side of the intended cut line, followed immediately by a knife that transects the tissue between the lines of deployed staples. In this way, the stapler seals the tissue on either side of the cut to prevent hemorrhage.

2. Surgical staplers are complex devices—successful use requires meticulous technique, as well as an assessment of the target tissue—and problems during use are not uncommon.

a) FDA performed an event reporting analysis of 109,997 reports involving staples and surgical staplers found in its Manufacturer and User Facility Device Experience (MAUDE) and ASR databases since 2011.

(1) These reports were associated with 412 deaths, 11,181 serious injuries, and 98,404 malfunctions.

(2) As a result, FDA has proposed measures to reclassify staplers from Class I to Class II devices, a move that will require establishing special controls (e.g., special labeling requirements) in order to provide "reasonable assurance of safety and effectiveness."

b) In a retrospective study of 349 colorectal resections using a circular stapler, 19% of the procedures included a technical/use error that was associated with a higher risk of GI bleeding, the need for transfusions, and unplanned proximal diversions (Offodile et al. 2010). That is, nearly one in five of these cases involved a technical error associated with stapler use.

3. Among the stapler-related events of which ECRI Institute is aware, use errors such as the following were identified as contributing factors:

a) Selecting an incorrect staple size (see the figure).

(1) Using an undersized staple on tissue that is too thick can prevent staples from securely contacting the anvil and being bent into their fully closed shape; these staples can work their way free, allowing the staple line to open.

(2) Using an oversized staple on tissue that is too thin allows the staples to contact the anvil and be bent into the correct shape, but the staples will not completely compress the target tissue. Though the staples will remain in place, the resulting gaps in the staple line may allow leakage from between the tissue halves.

b) Interposing other instruments or excessive tissue between the jaws.

c) Knife damage as a result of firing over a contraindicated object, such as a clip.

d) Failure to follow the device IFU, including adhering to contraindications.

Matching stapler cartridge size to tissue thickness (as shown in the top image) is important for secure closure and hemostasis.         

4. Lack of familiarity with the specific stapler model to be used can contribute to such errors. ECRI Institute recommends model-specific training precisely because stapler design can vary significantly from one brand to the next, even for devices that are intended for the same purpose. As an example, the manual endoscopic linear surgical staplers sold by the two major stapler manufacturers currently differ in the following ways:

a) The design, selection, and color of the staple cartridges, as well as the range of tissue thicknesses for which each cartridge is intended

b) The method of cartridge installation and removal

c) The method of stapler head articulation

d) Whether the stapler must be unlocked to indicate firing readiness

e) Whether tissue compression is recommended before firing

f) The number of trigger pulls required for staple deployment and knife advancement

g) The method by which the stapler retracts the knife

h) The method for opening the stapler jaws after firing

i) The number of recommended uses on a single patient before disposal

5. Raising awareness about surgical stapler hazards and educating staff about proper use can have a positive impact:

a) In a multiple-choice test created to evaluate surgical residents' knowledge on stapler use, a 24-percentage-point increase in average scores (from 53% to 77%) was obtained after a 40-minute instructional session (McColl et al. 2009).

b) Though the study was small (n = 26, general surgery), it may indicate an existing knowledge gap in the material and the value of directed training. Hands-on training may even provide a more marked improvement.

6. The bottom line? Stapler operators need to be knowledgeable about staple size selection; the mechanisms of closure, deployment, and removal; and the ways in which a specific device might be misused (Deng et al. 2002).

Glossary

Bibliography

References

Resource List

Related Resources

2020 Top 10 Health Technology Hazards


 

Member Resources   

The following resources are accessible to members of ECRI Institute's Health Devices, Health Devices Gold, and SELECTplus programs.

1. 4 ways to prevent harm from surgical staplers. ECRI Blog 2019 Jul 15.

2. Before a surgical stapler fails [guidance article]. Health Devices 2001 Oct.

3. Reclassification of surgical staplers [podcast]. Smart Healthcare Safety 2019 Jul 2.

4. Surgical stapler hazards (hazard #8). In: Top 10 technology hazards: high-priority risks and what to do about them. Health Devices 2009 Nov.

5. Surgical stapler misuse and malfunctions. Hazard #9—top 10 health technology hazards for 2017. Health Devices 2016 Nov 4.

6. Surgical staplers: recommendations to reduce the risk of commonly reported problems. Health Devices Alerts 2016 Mar 17 (Accession No. H0312).

7. Using the wrong size surgical stapler cartridge can injure patients [hazard report]. Health Devices 2009 Apr.


 

References and Additional Resources

1. Deng DY, Meng MV, Nguyen HT, et al. Laparoscopic linear cutting stapler failure. Urology 2002 Sep;60(3):415-9.

2. Food and Drug Administration (FDA), U.S.:

a) Surgical staplers and staples [updated 2019 Jun 25].

b) FDA executive summary: reclassification of surgical staplers for internal use. Prepared for the May 30, 2019 Meeting of the General and Plastic and Surgery Devices Panel.

3. Fuller HJ, Paul DE, Williams LC. Surgical stapler adverse events in the Veterans Health Administration: root causes and lessons learned. Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care: Advancing the Cause. 2014 Jun;3(1):153-6. [For abstract, see: http://hcs.sagepub.com/content/3/1/153.full.pdf+html.]

4. Kaiser Health News articles on the topic:

a) Jewett C. Device-safety experts to FDA: make data public. Kaiser Health News 2019 Mar 27.

b) Lupkin S, Jewett C. More than half of surgical stapler malfunctions went to hidden FDA database. Kaiser Health News 2019 May 30.

5. McColl RJ, Karmali S, Reso A, et al. The effect of a focused instructional session on knowledge of surgical staplers in general surgery residents. J Surg Educ 2009 Sep-Oct;66(5):288-91.

6. Offodile AC 2nd, Feingold DL, Nasar A, et al. High incidence of technical errors involving the EEA circular stapler: a single institution experience. J Am Coll Surg 2010 Mar;210(3):331-5.

Topics and Metadata

Topics

Culture of Safety; Quality Assurance/Risk Management; Physician Preference Items

Caresetting

Ambulatory Surgery Center; Hospital Inpatient; Hospital Outpatient; Trauma Center

Clinical Specialty

Cardiothoracic Surgery; Gastroenterology; Obstetrics; Surgery

Roles

Clinical Practitioner; Materials Manager/Procurement Manager; Nurse; Patient Safety Officer; Regulator/Policy Maker

Information Type

Guidance

Phase of Diffusion

 

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Clinical Category

 

SourceBase Supplier

Product Catalog

MeSH

ICD9/ICD10

FDA SPN

SNOMED

HCPCS

Disease/Condition

 

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