OLYMPUS HIGH FREQUENCY CABLE

Description of Event or Problem

OLYMPUS WAS INFORMED DURING THE DEMONSTRATION OF AN ELECTROSURGICAL SYSTEM, TWO SALES REPRESENTATIVES REPORTED FEELING A SHOCK TO THE HAND WHILE OPERATING THE EQUIPMENT. THERE WAS NO PT INVOLVEMENT, AS THE USERS WERE OPERATING THE EQUIPMENT IN A TEST CONFIGURATION. NO MEDICAL INTERVENTION WAS REQUIRED AND BOTH INDIVIDUALS WERE SAID TO BE DOING FINE AFTER THE REPORTED EVENT.

Additional Manufacturer Narrative

OLYMPUS FOLLOWED UP WITH THE REPORTER AND WAS INFORMED THAT THE ELECTROSURGICAL UNIT WAS SET TO BIPOLAR MODE AT 200 CUT AND 200 COAG. WHEN THE FOOT PEDAL WAS PRESSED TO ACTIVATE THE UNIT, THE USERS REPORTEDLY FELT AN ELECTRIC SHOCK FROM THE WORKING ELEMENT. FOLLOWING THE EVENT, THE (B)(4) ELECTRODE WAS DISCARDED, HOWEVER, ALL OTHER EQUIPMENT USED IN THE DEMONSTRATION WAS ISOLATED AND FORWARDED TO OLYMPUS FOR EVALUATION. THE EVALUATION DID NOT DUPLICATE A SHOCK DURING FUNCTIONAL TESTING, HOWEVER, THE (B)(4) CABLE REFERENCED IN THIS REPORT FAILED ELECTRICAL HIGH POTENTIAL TESTING, WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CONCOMITANT DEVICES REFERENCED IN THIS REPORT WERE TESTED AND FOUND TO OPERATE APPROPRIATELY. THE HIGH FREQUENCY CABLE WILL BE FORWARDED TO THE ORIGINAL EQUIPMENT MFR FOR FURTHER EVAL. IF SIGNIFICANT ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS IS THE FIRST OF TWO MDRS RELATED TO THIS REPORT. REFERENCE MFR #9610773-2010-0016 FOR THE RELATED REPORT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.