Device product
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.
Z-1223-2026
Product summary
- Event
- Event 98007
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3361 units
- Official record key
device-enforcement:Z-1223-2026
Official wording
Reason: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Code information: 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
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.