HF-CABLE, BIPOLAR

Additional Manufacturer Narrative

E1 ESTABLISHMENT NAME: (B)(6). BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE EVENT WAS NOT CONFIRMED, AND THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR, ELECTRICITY DID NOT FLOW AS MUCH AS USUAL, AND AT SOME POINT, BEGAN TO FLOW AGAIN. WHEN ELECTRICITY STARTED FLOWING, NO OTHER OPERATIONS WERE BEING PERFORMED, ONLY TISSUE WAS BEING SCRAPED. THE PROCEDURE COMPLETED WITHOUT DELAY; THE IRRIGATION LIQUID WAS THOUGHT TO BE SALINE. UPON OBSERVING THE BLADDER INTERIOR POST-SURGERY, IT WAS FOUND THAT TISSUE IN THE AREA WHERE THE SHEATH WAS HAD BEEN BURNED WHITE. FOLLOW UP INFORMATION INDICATED THAT TREATMENT FOR THE BURN WAS PERFORMED AND ADDITIONALLY THAT THE MALFUNCTION WAS CAUSED BY DISCONNECTION OF THE CABLE. DESPITE MULTIPLE ATTEMPTS TO CLARIFY THE SEVERITY OF THE BURN, THE TREATMENT, AND THE PATIENT OUTCOME, NO DETAILS WERE OBTAINED.