Recall Z-2542-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Olympus Corporation of the Americas
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of compatible generators. The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return e
| Date | Aug 8, 2024 (initiated Jul 1, 2024) |
| Status | Open, Classified |
| Reason | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach |
| Root cause | Package design/selection |
| Action | Olympus issued Urgent Medical Device Removal letter on July 1, 2024. Letter states reason for recall, health risk and action to take: 1. Carefully read the content of this notification. 2. Examine your inventory and identify the above listed device(s) with the affected batch number. 3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus. When it is received, you will receive a credit for your affected device(s). 4. Olympus requests that you acknowledge receipt of this letter. Acces |
| Quantity | 4364 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023492 | EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS Gyrus Medical, Inc., Nov 13, 2002 |