Description of Event or Problem · 1
LATE IN THE MORING OF JUNE 22, 1992, AT THE CONCLUSION OF TONSILLECTOMY AND ADENOIDECTOMY SURGERY ON A PATIENT USING THE WECK MOMOPOLAR BAYONET COAGULATION FORCEPS, THE SURGEON NOTED THE GRADUAL APPEARANCE OF THERMAL-TYPE, LINEAR-SHAPED TISSUE INJURIES INVOLVING THE CHEEK LININGS AS WELL AS THE ANGLES OF THE PATIENT'S MOUTH. THE INJURIES APPEARED ON THOSE TISSUES CLOSEST TO THE INSULATED SHAFTS OF THE FORCEPS. USE OF THE FORCEPS WAS IMMEDIATELY TERMINATED. THE FORCEPS' SHAFTS WERE NOT PERCEPTIBLY WARM TO THE TOUCH, NOR WERE THERE ANY IMMEDIATELY APPARENT DEFECTS IN THE INSULATION COVERING THEM. THE PATIENT WAS GIVEN INTRAVENOUS CORTICOSTEROIDS AND ANTIBIOTICS AND RETURNED TO THE RECOVERY ROOM.AFTER THE PATIENT LEFT THE OPERATING ROOM, THE FORCEPS WERE TESTED BY BRINGING THEM CLOSE TO A METALLIC GROUND. AS THE POWER WAS INCREASED, ENERGY WAS SEEN TO ESCAPE THROUGH MULTIPLE OTHERWISE IMPERCEPTIBLE DEFECTS IN THE INSULATION COVERING THE FORCEPS' SHAFTS AND SPARKS FORMED WHICH BURNED THE INSULATION AWAY IN SEVERAL SPOTS. TESTING WAS STOPPED AND THE INSTRUMENT QUARANTINED.THREE OTHER PATIENTS HAD BEEN OPERATED UPON EARLIER THAT SAME DAY WITH THE SAME INSTRUMENT, BUT NO TISSUE INJURIES HAD BEEN APPARENT IN THE OPERATING ROOM. TWO OF THE THREE PATIENTS WERE REEXAMINED IN THE RECOVERY AREA ONE TO THREE HOURS AFTER THEIR SURGERY HAD ENDED, AND EACH WAS FOUND TO HAVE A SIMILAR THOUGH LESS SEVERE TISSUE INJURY. THE FIRST PATIENT WAS CONTACTED BY PHONE AND DID NOT SUSTAIN ANY INJURY. ALL PATIENTS WERE SEEN IN THE SURGEON'S OFFICE WITHIN FOUR DAYS FOLLOWING SURGERY, AND ONE CHILD WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF DEHYDRATION.TWO OLDER PATIENTS, OPERATED UPON TWO WEEKS EARLIER, HAD EACH SUSTAINED MILDER DELAYED IRRITATIONS INVOLVING TISSUES AT THE CORNERS OF THEIR MOUTHS. THE SURGEON HAD ATTRIBUTED THESE PROBLEMS TO ADVERSE REACTIONS TO AGENTS PLACED IN THE TONSIL AND ADENOIDAL EXCISION SITES TO PROTECT AGAINST POST-OPERATIVE BLEEDING. IN RETROSPECT, THESE PATIENTS ALSO WERE INJURED BY THE SAME INSTRUMENT.PATIENT INFORMATION:DATE OF EVENT AGE SEX MEDICAL STATUS6/22/92 10 F 36/22/92 6 F 36/22/92 5 M 36/10/92 20 F 36/10/92 15 F 3DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 3.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAR-92. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: ELECTRICAL PROBLEM. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.