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 used in surgeries to cut and coagulate tissues. This device is particularly essential in endoscopic procedures for precision and efficiency.
The electrosurgical knife may overheat during use, leading to potential burns and tip breakage. This can compromise surgical safety and effectiveness.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face risks during surgeries if the device is not recalled. Immediate action is necessary to prevent potential injuries.
Serial numbers and lot numbers can typically be found on the packaging or device itself.
Expect a refund or replacement processing time of 4-8 weeks.
Document all communications regarding the recall, including emails and phone calls. Keep receipts and any product packaging.
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.
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