Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting For...
Reason for Recall / Hazard
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Product Description & Identification
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Affected Products
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Additional Source Details
| Field | Value |
|---|---|
| City | Center Valley |
| State | PA |
| Event id | 98454 |
| Address 1 | 3500 Corporate Pkwy |
| Code info | Model: 920005PK; UDI: 00821925036178; Lot Numbers: All unexpired; |
| Postal code | 18034-8229 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 326 units |
| Reason for recall | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260225 |
| Initial firm notification | Letter |
| Center classification date | 20260325 |
Overview
- Recalling FirmOlympus Corporation of the Americas
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.