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Recall Observatory FDA recall evidence

Device product

Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses

Z-0295-2017

July 15, 2016

Class II

Product summary

Firm
Ethicon Endo-Surgery Inc
Event
Event 74701
Status
Terminated
Classification
Class II
Quantity
105
Official record key
device-enforcement:Z-0295-2017

Official wording

Reason: Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.

Code information: N91L48, N91L49, N91R40, N91R41, N91U0W, N91U0X

Distribution pattern: Worldwide Distribution - US including AL, AR, AZ, CA, CO,CT, DC, FL,GA, IA,IL,KS,KY,LA,MA,MD, ME, MI,MN,MO, MS, MT,NC, ND, NH,NJ, NM, NV, NY, OH, RI, TN, TX, VA, VT, WA, WI and Internationally to Brazil and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.