BURN AS BEST CAN BE ASCERTAINED, THE INSTRUMENT IN QUESTION WAS BEING USED IN CONJUNCTION WITH AN ACMI G93 LIGHT CORD AND A LUXTEC LX300 LIGHT SOURCE DURING A DOUBLE MASTECTOMY/RECONSTRUCTION. AT ONE POINT DURING THE RECONSTRUCTION PORTION OF THE CASE, THE RETRACTOR ? WHILE STILL ATTACHED TO THE CORD AND SOURCE, AND STILL ON ? WAS LAID ON THE PATIENT CAUSING TWO BURNS TO THE PATIENT?S BODY. HOSPITAL BIOMED IS CURRENTLY EVALUATING THE CORD AND THE LIGHT SOURCE IN CONJUNCTION WITH THEIR MANUFACTURERS. HOSPITAL RISK MANAGEMENT HAS CLAIMED THAT THEY WOULD BE WILLING TO RELEASE THE INSTRUMENT AFTER THEIR EVALUATIONS ARE COMPLETED. RISK MANAGEMENT HAS FILED WITH MEDWATCH.: ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER (B)(6) 2013: IT WAS REPORTED THAT THE PATIENT SUFFERED 3 MINOR BURNS 2 (TWO) UNDER THE LEFT BREAST AND 1 (ONE) MID STERNUM AREA. THE PROCEDURE WAS COMPLETED AS PLANNED. THE LUXTEC LIGHT CORD WAS AN ACMI?G93 BUT THE CUSTOMER DID NOT KNOW ANYTHING ELSE REGARDING THE CORD. .
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Patient 1
(B)(4). THE DEVICE WAS NOT MADE AVAILABLE B THE CUSTOMER. IF THE DEVICE BECOMES AVAILABLE A FOLLOW-UP MDR WILL BE SENT IN.
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Patient 1
(B)(4) OFF LABEL USE, NOT FOLLOWING INSTRUCTIONS FOR USE. PROBABLE ROOT CAUSE: USER ERROR WAS THE ROOT CAUSE OF ALL THE INCIDENTS IN WHICH THE CUSTOMER PROVIDED INFORMATION OR A RETURNED SAMPLE WAS AVAILABLE FOR EVALUATION. THE CLINICIANS WERE USING THE RETRACTORS IMPROPERLY AND NOT FOLLOWING ONE OR MORE OF THE DIRECTIONS FOUND IN THE IFU RESULTING IN AREAS OF THE DEVICE BECOMING HOT ENOUGH TO CAUSE MINOR BURNS. THE CURRENT DEVICE DESIGN IS SUCH THAT AN IMPROPERLY SIZED LIGHT CABLE, IMPROPER CLEANING, OVERUSE OF THE LIGHT SOURCE AND OTHER FACTORS MAY CAUSE THE DEVICE TO BECOME HOT. THE PRODUCTS INFORMATION, IFU 26-0067-C STATES: ?THIS DEVICE TRANSMITS HIGH ENERGY LIGHT. THE METAL CONNECTORS OF THE FIBER OPTIC BUNDLE AND THE EXPOSED TIP MAY BECOME HOT DURING USE. NEVER LAY THE DEVICE ON A PATIENT OR ON PATIENT DRAPES?.