HEMOSTAT

Description of Event or Problem

DURING SURGERY A PORTION OF THE HEMOSTAT WAS BROKEN OFF AND REMAINED IN PATIENT'S FOOT. REMOVED SAME DAY. CONFIRMED BY X-RAYDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA, INVALID DATA. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.