Description of Event or Problem · 1
THE SURGEON INITIALLY ASKED FOR THE LASER TO BE SET AT R WATTS. WHEN HE DID NOT GET THE DESIRED AFFECT HE HASKED FOR AN INCREASE IN THE WATTS. HE OBTAINED A DESIRED AFFECT AT 12 WATTS. IT WAS NOTED ON THE PATIENTS POST-OP VISIT TO HER DOCTOR THAT A SECOND DEGREE BURN HAD OCCURED AT THE TIME OF SURGERY BUT WAS NOT NOTED BY ANY OF THE OR TEAM MEMBERS. TJHIS OCCURED BY A LASER FIBER USED DURING ARTHROSCOPIC SURGERY. THE PATIENT RECEIVED TWO VISITS IN PERSON BY THE MEDICAL DIRECTOR AND/OR RNS TIMES 2. SHE USED SILVADENE CREAM AND CLEAN DRESSINGS ON A DAILY BASIS. SHE WAS OFFERED BY THE FACILITY (ALL EXPENSES PAID) TO SEE ANOTHER DOCTOR FOR A SECOND OPINION IF SHE CHOSE. TWO FOLLOW-UP PHONE CALLS ALSO OCCURED UNTIL THE BURN WAS HEALED. THE LASER FIBER THAT HAD BEEN USED DURING THE SURGICAL PROCEDURE WAS NOT AVAILABLE FOR TESTING SINCE IT HAD BEEN DISCARDED FOLLOWING USE. ANOTHER FIBER WAS USED AND THE LASER WAS PUT THROUGH A TEST ACCORDING TO MANUFACTURERS SPECIFICATIONS AND FOUND TO BE IN COMPLIANCE.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-APR-91. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: A DEVICE FROM SAME LOT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, DESIGN, INCORRECT TECHNIQUE/PROCEDURE, UNANTICIPATED SHORT TERM COMPLICATION OF PROCEDURE, COMPONENT FAILURE. CONCLUSION: INTERMITTENT FAILURE DIRECTLY CAUSED EVENT, DEVICE WAS OUT OF CALIBRATION, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED, USER EDUCATION PROVIDED, INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS DESTROYED/DISPOSED OF.