PED RETURN ELEC

Additional Manufacturer Narrative

(B)(4). THE INCIDENT GROUNDING PAD WAS DISCARDED BY THE SITE AND IS NOT AVAILABLE FOR EVALUATION. CONCOMITANT DEVICES - THE HANDSWITCH WAS ALSO DISCARDED BY THE SITE AND NOT AVAILABLE FOR EVALUATION. THE FORCETRIAD WAS RECEIVED FOR EVALUATION AND NOTHING WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION FOUND THE FORCETRIAD TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS.

Description of Event or Problem

THE CUSTOMER REPORTED THAT A PATIENT RECEIVED A BURN AT THE RETURN PAD SITE, ON THE UPPER BUTTOCKS, DURING AN URETEROPLASTY. NO MEDICAL INTERVENTION WAS REQUIRED. THE INCIDENT PAD WAS DISCARDED BY THE SITE. THE CUSTOMER ALSO REPORTED THAT THE FORCETRIAD, IN USE DURING THE PROCEDURE, WAS EXPERIENCING INTERMITTENT OCCURRENCE. NO ALARMS WERE HEARD AND THE REM (RETURN ELECTRODE MONITOR) INDICATOR WAS GREEN. THE PATIENT WAS NOT REPOSITIONED DURING THE CASE.