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Patient 1
FOOT PEDAL ON YAG LASER BECAME NON-FUNCTIONAL DURING SURGICAL CASE, AFTER CERVICAL INCISION BLEEDING COULD NOT BE STOPPED USING LASER. PHYSICIAN UTILIZED STITCHES INSTEAD. PATIENT LAST 600 CC BLOOD, AND WILL IF POSSIBLY REQUIRE ADDITIONAL CARE. MANUFACTURER/SERVICE REPRESENTATION CONTACTED AND NEW FOOT PEDAL SENT. WHEN INSTALLED, DEVICE WORKED. UTMB BIOMEDICAL ENGINEERING AND ELECTRONICS INSPECTED FOOT PEDAL, FINDING THAT AN INTERNAL WIRE HAD DISCONNECTED FROM A SWITCH. THERE WAS INADEQUATE STRAIN RELIEF ON THE WIRE WHICH WAS IBE IF SEVERAL LEADING TO THE CORD.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-FEB-92. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: MECHANICAL TESTS PERFORMED. RESULTS OF EVALUATION: FOOT SWITCH. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.