—#93674

Product

Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05

FDA product code: NLM — Laparoscope, General & Plastic Surgery, Reprocessed
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K070165, K070896, K072177
Affected lot / code info: Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05

Why it was recalled

The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product will not deliver energy to the jaws, resulting in the potential for a cut/transection without a seal. Ethicon Endo-Surgery identified this issue during a routine finished goods quality inspection.

Root cause (FDA determination)

Other

Action the firm took

Ethicon Endo-Surgery issued an Urgent: Device Recall, Event 2193 letter dated July 19, 2010 identifying the affected device, the issue prompting the recall, and actions to be taken by consignees. Consignees were instructed: Do not use the affected product. Identify and quarantine affected product from inventory. Complete the Business Reply form and fax to Stericycle at 877-597-9580 within three days To return product, place it in a box with a copy of the Business Reply form and mail to Stericycle using the pre-printed UPS shipping label. Replacement product should be received by the customer within 60 days of return of affected product. Customers can contact Stericycle about this recall at 877-243-7314 and referencing Event 2193.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution to the following states: AZ, AL, AZ, CA, CO, CT, FL, GA, IN, KY, MA, MD, MI, MO, MS, NC, NV, NY, OH, PA, TN, TX, WA, and WV.

Timeline

Recall initiated: 2010-07-09
Posted by FDA: 2010-09-30
Terminated: 2011-02-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93674. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.