Everest Bipolar Cutting Forceps Recalled for Potential Sterility Breach
Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may result in a sterility breach. Approximately 6985 units are affected and were distributed worldwide.
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: FDA Class II medical device recall involving potential sterility breach from packaging defects. This qualifies as a risk-of-harm product where injury has not yet been reported. No illnesses or injuries have been reported in the source material.
Plain-English summary
Olympus Corporation of the Americas is recalling Everest Bipolar Cutting Forceps, surgical instruments used in minimally invasive procedures. These devices are designed to pass through 5-mm or 10-mm cannulas and use electrosurgical energy to coagulate and cut tissue. Approximately 6985 units are affected by this recall.
The defect involves fractures and breakages in the packaging trays and Tyvek covers. These packaging defects may result in a sterility breach. For surgical instruments, maintaining sterility before use is a critical safety requirement.
The affected devices were distributed worldwide, including the United States, Canada, Germany, Australia, Singapore, and South Korea. Multiple batch numbers are involved in the recall.
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 c
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- packaging-defect
- sterility-breach
Distribution
Distributed nationwide across the United States.
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