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

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

Additional Manufacturer Narrative

THE MODEL/LOT NUMBER ARE UNKNOWN. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE SECOND DEVICE AND THE EVENT, 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.

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 2 OF 2).