Olympus Corporation of the Americas is recalling 444 PK-CF0533 cutting forceps distributed worldwide. The devices may have welding defects that can cause the jaw to break during surgery. Stop using the device and follow recall instructions from Olympus or your healthcare provider.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical 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 PK-CF0533 Cutting Forceps are surgical instruments used for RF cutting and coagulation in endoscopic or open procedures.
A welding defect may cause the jaw to fracture during clinical use, risking tissue injury and procedural complications.
This recall is not part of a broader industry pattern.
The defect could lead to jaw breakage during surgery, potentially delaying procedures and increasing the risk to patients.
Model PK-CF0533 and UDI 00821925035867 appear on device labels and packaging.
Remediation processing typically 4-8 weeks.
Keep copies of recall notices, device labels, serial numbers, UDI codes, photographs, and all correspondence with Olympus and healthcare providers.
Model PK-CF0533; UDI 00821925035867; Lot Numbers: All unexpired; Quantity: 444 units; Distribution: Worldwide (US, Canada, EU, Australia, and other regions)
No injuries or incidents have been reported.
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