—#148248

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

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K111111
Affected lot / code info: N91L48, N91L49, N91R40, N91R41, N91U0W, N91U0X

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

Ethicon sent an Urgent Medical Device Recall letter dated July 15, 2016, to all affected consignees via UPS next day mail. The letter identified the product, the problem, and the action to be taken by the customer. Consignees were instructed to examine their inventory immediately and quarantine any affected product and return to ENDOPATH. If product subject to the recall was further distributed consignees were instructed to notify the other facility and arrange for return of the affected product. Customer were instructed to complete the Business Reply Form confirming receipt of this letter and fax to Stericycle at 1-888-228-5719 or email to ethicon5182@stericycle.com. Customers with questions were instructed to contact the Ethicon Customer Support Center at 1-877-384-4266. For questions regarding this recall call 513-337-3582.

Recalling firm

Firm: Ethicon Endo-Surgery Inc
Address: 4545 Creek Rd, Blue Ash, Ohio 45242-2803

Distribution

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.

Timeline

Recall initiated: 2016-07-15
Posted by FDA: 2016-10-20
Terminated: 2017-02-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148248. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.