Olympus Corporation recalled 3,361 Single Use Electrosurgical Knives on February 17, 2024, due to burn risks from tip breakage. The recall affects model KD-645L, distributed nationwide. The defective knives may overheat and deteriorate during use, posing serious safety risks.
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-645L is designed for cutting and coagulating tissue during surgical procedures. Surgeons often use this device in endoscopic surgeries, including laparoscopic operations.
The knife's cutting mechanism may overheat, leading to deterioration and burning. This can result in tip breakage, posing burn risks during surgical use.
This recall is not part of a broader industry pattern.
The recall affects surgical procedures where the electrosurgical knife is used, potentially delaying medical interventions and posing serious safety risks.
Model numbers and lot numbers can usually be found on the packaging or the device itself.
Expect 4-6 weeks for the refund process after returning the product.
Keep a record of any correspondence with the manufacturer and take photos of the product if necessary.
The recalled product is the Olympus Single Use Electrosurgical Knife, model KD-645L. It consists of a handpiece and monopolar electrode designed for surgical procedures. The product was distributed across the United States.
Not sure what to do next? Our guide walks you through the process step by step.
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