OLYMPUS HIGH FREQUENCY CABLE

Additional Manufacturer Narrative

OLYMPUS FOLLOWED UP WITH THE USER FACILITY REGARDING THE REPORTED EVENT. THE USER FACILITY REPORTED TO HAVE INSPECTED THE CABLE PRIOR TO THE PROCEDURE AND DID NOT FIND ANY IRREGULARITIES. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION ALONG WITH THE THREE OLYMPUS ELECTRODES. THE EVALUATION FOUND A DEEP CUT ON THE CABLE SHEATH APPROXIMATELY 30.5 INCHES FROM THE ELECTROSURGICAL UNIT CONNECTOR AT THE PROXIMAL END OF THE CABLE, NOT THE DISTAL END AS REPORTED BY THE USER FACILITY. THE CUT WAS ANGLED, AND HAD SHEARED THROUGH APPROXIMATELY 80% OF THE CIRCUMFERENCE OF THE CABLE JACKET, EXPOSING CABLE WIRING. EVIDENCE OF THERMAL DAMAGE AND STAIN RESIDUE WERE FOUND ON THE SURFACE OF THE EXPOSED WIRES. THE CAUSE OF THE REPORTED PHENOMENON WAS DETERMINED TO BE DUE TO PHYSICAL DAMAGE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

Description of Event or Problem

THE USER FACILITY REPORTED TO HAVE OBSERVED SMOKE COMING FROM THE DISTAL PORTION OF THE CABLE UPON THE COMPLETION OF A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE. THE CABLE WAS REPORTED TO HAVE BEEN PLACED IN THE PATIENT'S LAP DURING THE PROCEDURE. WHEN THE SURGICAL DRAPE WAS REMOVED, WHAT WAS DESCRIBED AS A THIRD-DEGREE BURN WAS FOUND ON THE PATIENT'S THIGH. A SECOND SURGEON REPORTEDLY DRESSED THE BURN AND PROVIDED MEDICAL TREATMENT, AND THE PATIENT WAS SAID NOT TO HAVE REQUIRED HOSPITALIZATION. THE PATIENT IS REPORTEDLY DOING FINE, BUT THE BURN HAS NOT COMPLETELY HEALED AS OF YET.