Olympus Corporation of the Americas: Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upp

Hazard

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

Details from the source

Reason for recall: 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 Distribution: Nationwide Quantity: 4507 units Lot/code info: UDI-DI: 04953170208423 All lots numbers

UPC codes

04953170208423

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.