D
Patient 1
IT WAS REPORTED THAT DURING A PROSTATE ABLATION PROCEDURE, THE FIBER TIP DETACHED FROM THE FIBER SHAFT AND REMAINED IN THE PT'S BLADDER. A PROSTATIC URETHERAL IRRIGATION WASHOUT WAS UNSUCCESSFUL IN REMOVING THE REPORTED INDWELLING TIP. THE FIBER TIP IS STILLUNACCOUNTED FOR. NO FURTHER COMPLICATIONS WERE REPORTED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.