Recall Z-1167-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Olympus Corporation of the Americas
ESG PK CUTTING FORCEPS, 5MM, 33CM
| Date | Feb 20, 2024 (initiated Dec 15, 2023) |
| Status | Open, Classified |
| Reason | The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure. |
| Root cause | Under Investigation by firm |
| Action | On January 15, 2024, the firm notified customers of the issue via URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect your inventory and identify any products of the model and lots subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lots. Customers were given detailed instructions on how to identify affected product. Please contact your Olympus customer service representative at 1-800-848-9024, option 2 with the quantity, model and lot number of the affect |
| Quantity | 11,123 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Mexico, P.R. China, Singapore, South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps Olympus Winter & Ibe GmbH, Apr 28, 2021 |