FDA-Device2024-09-18Class II
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
Olympus Corporation of the Americas
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
Sold states
Nationwide
Affected count
2525 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1548-2024Don't want to check this manually?
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