ECRI Institute’s Accident and Forensic Investigation Group provides specialized services to investigate, analyze, and prevent incidents, injuries, and deaths related to medical device failures and organization systems and processes.
ECRI Institute regularly investigates incidents involving surgical staplers; some incidents have had devastating, even fatal, consequences.
About surgical staplers
Surgical staplers expedite surgical procedures by replacing tedious manual suturing. These disposable devices can make surgery less traumatic for the patient and often allow the surgeon to perform complex procedures that otherwise could not be accomplished. But like any medical device, staplers occasionally fail to perform as expected. Although not all failures harm the patient, ECRI Institute is aware of numerous cases in which prolongation of surgery, serious tissue injury, and even death have resulted.
Staplers are used in a wide range of surgical procedures. The device consists of a stapler body, a staple cartridge or reload (which houses multiple lines of staples), an anvil, and a firing mechanism (e.g., pistol grip handles). The staple cartridge and anvil assemblies form the jaws of the instrument. To operate, the user first loads a staple cartridge into the stapler (unless the stapler comes preloaded by the manufacturer). The user then places the target tissue between the stapler jaws and activates the firing mechanism. Many staplers also have a knife that automatically transects the tissue when the stapler is fired.
“The operation of surgical staplers seems simple,” says an accident investigator. “But everything must be properly executed with the right stapling cartridge, the right thickness of tissue, and the proper positioning of tissue in the stapler’s jaws.” Often, ECRI Institute’s investigations of adverse events from surgical staplers identify errors in user technique as the cause.
Common user errors
While many factors can contribute to adverse outcomes, ECRI Institute’s investigations have identified the following common user errors associated with surgical staplers:
- Failure to properly position the stapler jaws on the tissue to be stapled
- Improper matching of stapler cartridge size to tissue thickness
- Uneven distribution of the tissue in the stapler’s jaws
- Clamping of the stapler on a nearby instrument
- Too much tension on tissue during stapling
- Failure to correctly fire the stapler (e.g., not fully pulling the firing trigger, pulling too forcefully and breaking the stapler’s interlocks)
Each of these can have disastrous consequences. If the stapler jaws are not properly placed, leakage, blood loss, and staple line opening can occur, extending or defeating the proposed surgery. With vascular stapling, blood loss can be rapid and extensive, requiring immediate surgery. An undersized staple line might tear from the tissue, allowing the staple line to open. An oversized staple line may result in gaps in the staple line and leakage. If the stapler isn’t fired properly, the staples won’t be properly formed and could pull out.
Physicians must be proficient in the instruments and technology that they use. While the benefits of staplers for patients in shortening procedure times often outweigh the risks, the devices must be used with care. All users should be expected to read the instructions for use that accompany these devices. By familiarizing themselves with this information, staff will be aware of performance that deviates from normal device function.
Not every contingency or complication is covered in the instructions. Staff should understand that unpredictable failures occasionally occur, and they should know how to quickly and carefully resolve the situation. For instance, staplers’ jaws have been reported to become locked around tissue. Remaining calm while inspecting the device and determining how to open it will help avoid causing additional tissue trauma.
Before beginning a procedure, staff should always have backup plans in place should a stapler fail. For example, one backup plan is to ensure that additional units are immediately available for surgical staff to use if a unit is suspected of being faulty. Another backup plan is to have clamps immediately ready to close off the cut in case the staple line is not effective.
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We can help your organization react quickly and knowledgeably to restore operations and maintain confidence after an incident. Our services are undertaken in strict confidence within the limits of ethical and legal confidentiality principles.