Description of Event or Problem · 1
M.D. WAS USING THE FLOW. DURING PROCEDURE HE WAS COMPLAINING ABOUT THE HANDPIECE GETTING HOT. IT WAS NOTICED WHEN HE GOT SHOCKED THAT THERE WAS ACCUMULATION OF TISSUE ON THE END OF THE ELECTRODE THAT COULD HAVE CAUSED THE ELECTRICITY TO GAP TO THE OUTER SHEATH AND SHOCK HIS HAND THAT WAS HOLDING, STEADYING THE OUTER SHEATH. NO INJURY TO PATIENT.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.