Description of Event or Problem · 1
FACILITY (B)(4) REPORTED THE FOLLOWING: PROCEDURE: DILATION AND CURETTAGE, HYSTEROSCOPY, OPERATIVE WITH ROLLERBALL. DURING AN ABLATION USING AN ERBE MACHINE, THE HAND PIECE WORKED ON AND OFF. MOVED GENERATOR SETTING FROM 5 TO 7 THEN BACK TO 5 ON BOTH BIPOLAR SETTINGS. ELEMENT WAS RED HOT, A LOUD POP WAS HEARD AND SALINE WAS TOSSED ON PT'S GROIN. BLAST OF LIGHT OBSERVED. PT VITALS REMAINED STABLE AND NO BURNS WERE SEEN, EXTERNAL OR INTERNAL. BIPOLAR CABLE WAS APPROX 5 YEARS OLD. EQUIPMENT SENT TO BIOMED FOR INVESTIGATION. NO SIGNS OF DAMAGE ON WOLF HANDPIECE OR DISPOSABLE TIP. DAMAGE SEEN ON CABLE JUST BEFORE IT BIFURCATES AND ON OUTFLOW TUBING WHERE CABLE WAS TOUCHING. BIOMED TESTED SAME SETUP WITH NEW BIPOLAR CABLE AND ITEMS OPERATED NORMALLY. USER FACILITY SUBMITTED THE PHOTOS OF THE BURNT CABLE FOR EVAL. A FULL INVESTIGATION COULD NOT BE COMPLETED AS THE ACTUAL DEVICE WAS NOT RETURNED TO THE RICHARD WOLF FACILITY AS OF 08/02/2012. EXAMINATION OF THE PHOTOS REVEALED A CABLE THAT APPEARS TO BE WORN FROM NORMAL WEAR AND TEAR. MOST LIKELY THERE WERE BROKEN WIRE STRANDS, DUE TO NORMAL USAGE, CAUSING A HEAT BUILD UP AND ARCING (EXPLOSION - THE POP NOISE) RESULTING IN A BROKEN ELECTRICAL CONNECTION. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. I.E., INTENDED USE, INDICATION AND FIELD OF USE, PREPARATION AND CAUTIONS. REPORTS ON THIS DEVICE WERE REVIEWED, NO TRENDS WERE NOTED. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE THE DEVICE OR ADDITIONAL INFO, WE WILL PROVIDE FDA WITH FOLLOW-UP INFO.