RE-USABLE ACTIVE CORD

Description of Event or Problem

DURING A TURP PROCEDURE AT (B)(6) HOSPITAL, THE SURGEON, RECEIVED A SHOCK WHEN ACTIVATING THE CAUTERY UNIT. OTHER DEVICES USED WITH THE RAC-B ACTIVE CORD HAVE NOT YET BEEN IDENTIFIED (MODEL OR MANUFACTURER) AND WE ARE STILL GATHERING INFORMATION FROM THE FACILITY.

Additional Manufacturer Narrative

VISUAL EXAMINATION OF THE RAC-B INSTRUMENT FINDS THAT THE CORD IS COMPLETELY SEVERED JUST PROXIMAL TO THE ELECTRODE CONNECTOR BODY. ALL OF THE WIRES AT THE SEPARATED SECTION OF CORD EXHIBIT SIGNS OF CHARRING AND MELTING AT THEIR TIPS. THE WIRE BUNDLE INSIDE EACH END OF THE CORD APPEARS TO BE OTHERWISE INTACT. THE BALANCE OF THE INSULATED WIRE CORD IS IN GOOD PHYSICAL CONDITION WITH NO SIGNS OF ABUSE OR EXCESSIVE WEAR. THE EXACT CAUSE OF THE FAILURE IS UNK. ANY SIGN OF EXTERNAL DAMAGE TO THE WIRE INSULATION WOULD HAVE BEEN LOST DUE TO THE MELTING AND CHARRING OF THE CORD. THE MOST LIKELY CAUSE OF THE FAILURE WOULD BE A CUT OR OTHER DAMAGE TO THE CORD IN THE FAILURE REGION, WHICH WOULD LEAD TO AN ELECTRICAL SHORT CONDITION DURING ACTIVATION TO ANY NEARBY GROUNDED OBJECT. THIS SHORT CONDITION WOULD THEN PRODUCE ARCING AND BURNING OF THE WIRES AND INSULATION, RESULTING IN THE ULTIMATE FAILURE OF THE CORD.