HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THE RESECTION ELECTRODE HAD A COMPLETE FRACTURE AT THE METAL RING ROOT OF THE ELECTRODE TIP. THE ISSUE WAS FOUND DURING A THERAPEUTIC TRANSURETHRAL RESECTION (USING DISPOSABLE HF RING RESECTION ELECTRODE) AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.