Description of Event or Problem · 1
PATIENT SCHEDULED FOR ARTHROSCOPIC LATERAL RETINACULAR RELEASE - RIGHT KNEE. PROCEDURE DONE WITH ELECTROCAUTERY UNIT. DOCTOR CONNECTED A HEMOSTAT TO CAUTERY TIP TO PREVENT THE TIP FROM TURNING INSIDE THE KNEE. THE INSULATION ON THE CAUTERY TIP WAS BROKEN AND THE HEMOSTAT CAME IN CONTACT WITH THE PATIENT'S SKIN, CAUSING IT TO CAUTERIZE THE TISSUE OF THE KNEE. PATIENT SUFFERED 2 CM FULL THICKNESS BURN @ ANTERMODIAL PORTAL. PATIENT TAKEN TAKEN TO RECOVERY ROOM IN SATISFACTORY 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.