Approximately 7,032 Olympus Triangle Tip Electrosurgical Knives are being recalled because the knife tip can break off during medical procedures. This recall affects models KD-640L (4,507 units) and KD-645L (2,525 units), which are used during endoscopic surgery to cut tissue in the upper digestive tract. Olympus has received an increase in complaints regarding these breakages, including reports of serious injuries during use. Olympus is issuing a reminder to healthcare providers to ensure the knives are used strictly according to instructions regarding compatible electrosurgical unit settings.
The electrosurgical knife tip can break off while inside a patient if used with incompatible equipment or settings. This can lead to serious internal injury, unintended tissue damage, or the need for additional procedures to retrieve the broken fragments.
User notification and usage reminder
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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