Olympus Corporation of the Americas recalled the Single Use Electrosurgical Knife KD-640L on February 17, 2024. The recall follows reports of overheating and potential tip breakage during surgery. Healthcare providers and patients must stop using the device immediately to avoid injuries.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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The Olympus Single Use Electrosurgical Knife KD-640L is designed for cutting and coagulating tissues during surgeries. The affected model numbers include KD640-L and UDI 04953170208423, with lot numbers ranging from 2ZK to 47K. The device is distributed nationwide in the U.S.
The electrosurgical knife may overheat and burn during procedures, leading to tip breakage. This poses a high risk of injury to patients and can complicate surgical procedures.
No specific incidents or injuries have been reported at this time. The recall addresses potential risks identified by the manufacturer.
Stop using the Olympus Single Use Electrosurgical Knife immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions and to follow the recall process.
For recall details, call Olympus Corporation of the Americas at 1-800-XXXX-XXXX. More information is available at the FDA's recall page.
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