device · product 1 of 2
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
- Recall number
- Z-0295-2017
- Initiated
- July 15, 2016
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 105
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Device Design
Inspect official wording and provenance
Reason for recall
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.