Description of Event or Problem · 1
DURING CYSTOSCOPY AND URETERAL MEATOTOMY ONE BLADE OF SCISSOR BROKE AWAY. THE SCISSORS WERE REMOVED. A GUIDE WIRE WAS INTRODUCED AND PLACED NEAR THE RENAL STONE. FLUOROSCOPY WAS UTILIZED FOR PLACEMENT OF WIRE AND VISUALIZATION OF BLADDER AND SURROUNDING STRUCTURES, NO FOREIGN BODY/MATERIAL WAS NOTEDDEVICE NOT 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. 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: END OF LIFE - EXPECTED, EXPECTED WEAR/DETERIORATION. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP, DEVICE UNAVAILABLE FOR FOLLOW-UP INVESTIGATION EXAMINATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED, DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS DESTROYED/DISPOSED OF.