Olympus Electrosurgical Knives Recalled Due to Breakage During Use
Olympus Corporation recalled 2,525 electrosurgical knives (KD-645L) nationwide after reports of serious injury from knives breaking off during use. Users must follow Instructions for Use regarding proper electrosurgical unit compatibility and output settings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall with documented reports of serious injury from the hazard. Per the rubric, FDA Class II recalls with injury reports constitute Severe (score 4).
Plain-English summary
Olympus Corporation of the Americas has recalled 2,525 Triangle Tip Electrosurgical Knives (Model KD-645L) distributed nationwide. These surgical instruments are used with Olympus endoscopes and electrosurgical units to cut tissue in the upper digestive tract during medical procedures.
The recall was issued following reports of serious injury caused by knives breaking off during use. The root cause is improper use of the instruments in relation to electrosurgical unit compatibility and output settings that do not comply with the manufacturer's Instructions for Use.
Healthcare facilities and practitioners using these instruments should immediately review the Instructions for Use to ensure they are following proper specifications for electrosurgical unit compatibility and output settings before continued use. The affected product is identified by UDI-DI 04953170407857 and applies to all lot numbers.
The recalled product
- 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
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 2,525
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: - 04953170407857 All lots numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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