Olympus Everest bipolar cutting forceps jaws may break from defective welds
Olympus is recalling Everest Bipolar Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the jaw may break inside a patient during a procedure, and no injuries are stated in the source.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Everest Bipolar Cutting Forceps with Cord, 5 mm 33 cm, model 3006. The forceps are passed through a 5 mm cannula, achieving coagulation using electrosurgical energy under visualisation with the bipolar outputs of compatible generators. About 164 units were distributed nationwide in the United States and to Canada, Mexico, the EU, Australia, China, Singapore, Korea and Japan. The FDA has classified this recall as Class II.
Olympus identified that the cutting forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the forceps' jaw breaking during clinical use.
All unexpired lot numbers are affected. The device carries UDI 00821925035898.
Facilities can identify affected forceps by the model number and UDI above, and may contact Olympus Corporation of the Americas for further information.
The recalled product
- Product
- Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achi
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 164
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 (3)
- Model: 3006
- UDI: 00821925035898
- Lot Numbers: All unexpired
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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