D
Patient 1
THE PT PRESENTED FOR ROUTNE D&E. SHE WAS PREPPED WITH BETADINE AND WAS LOCALLY ANESTHETISED WITH LIDOCAINE AS IS ALSO USUAL. PRATT DILATORS SEQUENTIALLY FROM #15 TO #23 WERE INSERTED INTO THE CERVICAL WITHOUT DIFFICULTY, THEN THE #7 VACURETTE PASSAGE WAS ATTEMPTED. IT DID NOT PASS EASILY, SO THE PHYSICIAN TOOK IT OUT, EXAMINED IT AND DETERMINED THERE WERE NO PROBLEMS, THEN REINSERTED IT. AT THAT TIME IT WENT IN EASILY AND THE SUCTION D&E WAS PERFORMED WITHOUT DIFFICULTY OR INCIDENT. WHEN THE VACURETTE WAS WITHDRAWN PRIOR TO THE ROUTINE SHARP CURETTAGE, SEVERAL CRACKS AND A SMALL 1-2 MM DEFECT IN THE PLASTIC TIP WERE NOTED. THE 1-2 MM PIECE OF THE VACURETTE WAS BROKEN OFF AND MISSING. A CAREFUL SHARP CURETTAGE WAS PERFORMED FOLLOWED BY REPEAT SUCTION WITH A FRESH, UNBROKEN #7 VACURETTE. AFTER AN INITIAL 5 CC OF BLOOD, NO FURTHER BLOOD, TISSUE, OR DEBRIS WAS OBTAINED FROM THE UTERUS DESPITE 2 MINUTES OF CAREFUL SUCTIONING IN ALL QUADRANTS. PT HAD A NORMAL POST OPERATIVE COURSE THE DAY OF SURGERY, AND WAS DISCHARGED HOME WITH AN ULTRASOUND SCHEDULED FOR THE MORNING OF THE NEXT DAY (4/7/95).DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: MANUFACTURING, MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.