Medical Device Recall: 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-640L
Olympus Corporation of the Americas · March 1, 2024
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
States Affected
NATIONWIDE
Quantity Affected
4507 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1547-2024
Status: ongoing
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