Medtronic—Covidien EEA Hemorrhoid and Prolapse Stapler Sets with DST Series Technology: Yellow Staple Guide May Be Improperly Welded to the Instrument
April 18, 2018 | Risk Management News
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In an April 9, 2018, Urgent Medical Device Recall letter submitted by ECRI Institute member hospitals, Medtronic states that the yellow staple guide may be improperly welded to the above staplers. Use of a device with an improperly welded staple guide may result in improper staple formation, potentially leading to bleeding or anastomotic leak. Medtronic also that it has received no reports of serious injury related to this problem. The manufacturer has not confirmed the...