Device product
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-645L
Z-1548-2024
Product summary
- Event
- Event 94173
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2525 units
- Official record key
device-enforcement:Z-1548-2024
Official wording
Reason: Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury
Code information: UDI-DI: - 04953170407857 All lots numbers
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury