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

Description of Event or Problem

IT WAS REPORTED, DURING THE BLADDER RESECTION PROCEDURE, THE HIGH FREQUENCY RESECTION ELECTRODE LOOP "WAS USED FOR 15 MINUTES, THEN FUSED AND FRACTURED. THEN, A NEW LOOP WAS USED; AFTER 5 MINUTES, IT WAS AGAIN FUSED AND FRACTURED. THE ELECTRIC RESECTION WAS SET AT 280 DURING THE PROCEDURE. THE DEVICE WAS REPLACED TO CONTINUE THE PROCEDURE, AND IT DID NOT HAVE ANY IMPACTS ON THE PATIENT." (DEVICE 1 OF 2).

Additional Manufacturer Narrative

THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. HOWEVER, THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.