Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Singl...
Reason for Recall / Hazard
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Product Description & Identification
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
Affected Products
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
Additional Source Details
| Field | Value |
|---|---|
| City | Center Valley |
| State | PA |
| Event id | 98007 |
| Address 1 | 3500 Corporate Pkwy |
| Address 2 | N/A |
| Code info | Model/Catalog Number: KD-645L UDI: 04953170407857 Lot Number(s): 2ZK, 31K, 32K, 33K, 35K, 3XK, 3YK, 3ZK, 42K, 43K, 44K, 45K, 46K, 47K, 48K, 49K, 4XK, 4YK, 4ZK, 51K, 52K, 53K, 54K, 55K, 56K, 57K, 58K, 59K |
| Postal code | 18034-8229 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 3361 units |
| Reason for recall | A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20240217 |
| Initial firm notification | Letter |
| Center classification date | 20260130 |
Overview
- Recalling FirmOlympus Corporation of the Americas
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.