OLYMPUS HIGH FREQUENCY RESECTION ELECTRODE

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A TRANSURETHRAL RESECTION OF PROSTATE (TURP) PROCEDURE, APPROXIMATELY HALFWAY THROUGH THE PROCEDURE, THE USER NOTED THAT THE LOOP PORTION OF THE ELECTRODE HAD BROKEN OFF. A PORTION OF THE LOOP WAS OBSERVED IN THE BLADDER UNDER DIRECT VISUALIZATION. HOWEVER, WHEN THE USER ATTEMPTED TO REMOVE THE FRAGMENT, IT COULD NOT BE LOCATED. AN X-RAY WAS PERFORMED, HOWEVER, THE RESULT WAS SAID TO BE NEGATIVE. THE PROCEDURE WAS COMPLETED WITH UNK DEVICE AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM. THERE WAS NO PATIENT HARM REPORTED.

Additional Manufacturer Narrative

OLYMPUS FOLLOWED UP ON THIS REPORT AND WAS INFORMED THAT AT THE TIME OF THE PROCEDURE THE USERS HAD SEARCH IN AND AROUND THE STERILE FIELD AND DRAPES FOR THE LOOP FRAGMENT, BUT NOTHING WAS FOUND. FOLLOWING THE COMPLETION OF THE CASE, THE ELECTROSURGICAL UNIT AND BIPOLAR CORD WERE CHECKED BY THE CLINICAL ENGINEERING STAFF AND REPORTED THAT THERE WERE NO ANOMALIES FOUND AND THE CORD WERE FUNCTIONING APPROPRIATELY AND WERE RETURNED TO SERVICE. THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. IF THE EQUIPMENT ASSOCIATED WITH THIS REPORT IS RETURNED FOR EVALUATION. OR IF ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION. OLYMPUS AMERICA INC IS FILING MDRS ON BEHALF OF GYRUS ACMI AND OLYMPUS MEDICAL SYSTEMS CORPORATION, (B)(4). GYRUS ACMI REGISTRATION NUMBERS: (B)(4).