Olympus recalls 7 PKS Cutting Forceps worldwide because welded components may fail. The devices are used with a 5mm cannula and an electrosurgical generator. Stop using the device and follow the manufacturer’s recall instructions. Healthcare facilities should verify device details and consult Olympus for replacement options.
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 PKS Cutting Forceps are designed to pass through a 5mm cannula and are used with an electrosurgical generator for coagulation under visualization.
The supplier welding validation issue can lead to jaw fracture under clinical use, creating a risk of instrument failure and potential injury.
This recall is not part of a broader industry pattern.
Hospitals and clinics must halt use of the affected devices and coordinate with Olympus for replacement or refund while ensuring patient safety.
UDI printed on packaging and device label; Model 920000PK identifier on instrument and documentation.
4-6 weeks for refund or replacement processing.
Retain all recall notices, purchase records, serials/UDI, and correspondence with the manufacturer for potential claims.
Model: 920000PK. Distribution: Worldwide (US nationwide and additional countries). Sold: All unexpired lots. Price: Unknown.
No injuries or incidents have been reported.
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