Olympus Everest Bipolar Cutting Forceps Recalled for Packaging Defects
Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may compromise sterility. The recall affects 4,364 units distributed worldwide.
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 3/5 (High).
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: This Class II medical device recall involves a surgical instrument with a documented packaging defect that may compromise sterility. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm medical devices where injury has not yet been reported receive a High rating.
Plain-English summary
Olympus Corporation of the Americas is recalling Everest Bipolar Cutting Forceps due to packaging defects. Fractures and breakages have been identified in the packaging trays and Tyvek covers used to maintain sterility of these surgical instruments.
These packaging defects may result in a breach of sterility. The forceps are electrical surgical instruments designed for use in minimally invasive procedures, where they are used to grasp, coagulate, and cut tissue. Compromised sterility could affect the safety of use in sterile surgical environments.
Approximately 4,364 units have been distributed worldwide, including throughout the United States and internationally to Canada, Germany, Australia, Singapore, and South Korea. Affected batches have been identified with specific batch numbers issued by the manufacturer.
The recalled product
- Product
- The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 4,364
Distribution
Part of a larger recall action
This product is one of 3 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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