Olympus Electrosurgical Knives Recalled for Breaking During Use
Olympus Corporation recalls 4,507 Triangle Tip Electrosurgical Knives (Model KD-640L) due to device fragmentation during use. The issue is linked to reports of serious injury and improper adherence to usage instructions.
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: FDA Class II designation combined with reports of serious injury from device fragmentation during use. The occurrence of injury reports, beyond theoretical risk, meets the rubric criterion for Severe classification.
Plain-English summary
Olympus Corporation of the Americas is recalling 4,507 Triangle Tip Electrosurgical Knives (Model KD-640L) distributed nationwide. The knives are designed to cut tissue during upper digestive tract procedures but are breaking off during clinical use.
Reports of serious injury have been associated with device fragmentation. Olympus attributes the issue to users not following the Instructions for Use, which specify critical compatibility requirements with electrosurgical units and appropriate output settings.
Clinicians and healthcare facilities using these devices should review and adhere to the Instructions for Use regarding proper electrosurgical unit compatibility and output specifications to prevent device breakage and associated injury.
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-640L
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 4,507
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: 04953170208423 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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