HF RESECTION ELECTRODE - BUTTON

Additional Manufacturer Narrative

THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION COULD NOT CONFIRM THE REPORTED PHENOMENON OF DEVICE CAUSING A SHOCK. IT WAS NOTED THAT THE LOOP WAS IN GOOD CONDITION, HOWEVER, THE ELECTRODE WAS BENT AT THE DISTAL END AND THE BACK TIP WAS WORN OUT, NEAR THE CONNECTION TO THE TEFLON BODY. THE TEFLON BODY OF THE ELECTRODE WAS UNABLE TO LOCK/HOLD THE ELECTRODE DUE TO THE WORN OUT BACK TIP. IT IS BELIEVED THIS COULD BE ATTRIBUTED TO THE BACK TIP BEING WORN OUT OR A DAMAGED LOCKING MECHANISM INSIDE THE TEFLON BODY. PLEASE REFERENCE ASSOCIATED DEVICES REPORTED: MFR REPORT #: 2951238-2014-00259.

Description of Event or Problem

OLYMPUS WAS INFORMED THAT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP), THE PHYSICIAN WAS SHOCKED AND THE PATIENT'S LEG JERKED. THE PHYSICIAN TURNED OFF THE BIPOLAR CUTTING AND REMOVED THE DEVICE AND NOTED THAT THE LOOP HAD BROKEN AND WAS MELTED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PHYSICIAN NOR THE PATIENT REQUIRED ANY TREATMENT AND THE PATIENT WAS SENT HOME.