Description of Event or Problem · 1
DURING SURGERY THE YAG LASER FAILED TO PROVIDE PROPER POWER OUTPUT. POWER AS INCREASED FROM 60 TO 80 WATTS WITHOUT EFFECT.THE FIBER WAS CHANGED WITHOUT EFFECT. THE LASER OPTION WAS ABANDONED AND THE PROSTATE WAS INCISED WITH ELECTROSURGERY. THIS WAS NOT THE METHOD OF CHOICE BECAUSE OF THE PATIENT'S PRE-EXISTING CONDITION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.