Description of Event or Problem · 1
A SURGIWAND II MADE BY COVIDIEN WAS USED IN A RECENT SURGERY. THE PLASTIC COATING ON THE CAUTERY TIP MELTED AND FELL OFF INTO THE PT'S ABDOMEN. THE PLASTIC WAS RETRIEVED AND NO HARM CAME TO THE PT. THIS WAS THE STATEMENT FROM THE OPERATING ROOM NURSE: SCOPE CHOLE PROCEDURE, USING A SURGIWAND II. CONMED BOVIE #0093 SET AT 50 COAG AND 50 CUT TO START THE PROCEDURE. WHILE USING THIS INSTRUMENT THE TIP FELL OFF. DR RETRIEVED TIP AND TOOK OUT OF THE ABD. FURTHER IN THE CASE HE ASKED FOR THE COAG TO BE TURNED UP AS HIGH AS IT WOULD GO -120. CIRCULATOR TOLD HIM IT WAS 120 AND HE SAID OKAY. WE HAD OUR BIOMED GUY TAKE A LOOK AT THE DEVICE AND THIS IS HIS RESPONSE: DID VISUAL EXAMINATION OF SURGIWAND II. OBVIOUS CHARRING OF OUTER SHEATH AND INNER ELECTRODE. TESTED OUTPUTS OF CONMED 5000 (B)(4) USING METRON QA-ES MKII ANALYZER -(B)(4)- CALIBRATED (B)(6) 2010. ALL MEASURED OUTPUTS WITHIN MFR'S SPECS. MAX VOLTAGE RATING FOR SURGIWAND II IS 4500 VP-P. THE CONMED DID PUT OUT 5600 VP-P WHEN LOAD WAS INCREASED TO 10X MFR'S SPEC -5000 OHMS INSTEAD OF 500 OHMS. TWO POSSIBLE SCENARIOS ARE POSSIBLE. ONE, THE LOSS OF THE TIP INCREASED THE RESISTANCE TO THE CURRENT PATH SUFFICIENTLY TO CAUSE THE CONMED TO INCREASE VOLTAGE TO A LEVEL BEYOND THE SURGIWAND II'S RATING. TWO, THE SURGIWAND II WAS DEFECTIVE. (B)(6), BIOMED. DATES OF USE: NOT SURE. DIAGNOSIS OR REASON FOR USE: CAUTERY DURING OPERATING ROOM PROCEDURE.