Description of Event or Problem · 1
PATIENT REPORTED TO THIS FACILITY TO HAVE BREAST IMPLANTS REMOVED SURGICALLY. PATIENTS STATES THAT SHE HAD A SONOGRAM AND WAS TOLD THAT ONE OF THE IMPLANTS MAY HAVE BROKEN/LEAK IMPLANTS REMOVED AND ON RIGHT SIDE IT WAS NOTED BY THE PHYSICIAN THAT THERE WAS SOME LEAKAGE IN TO THE CAPASULAR AREA. BOTH IMPLANTS WERE REMOVED LEFT ON APPEARED TO BE INTACT. PATIENT WAS KNOWLEDGEABLE AND EXPRESSED THAT SHE UNDERSTANDS THE PROCEDURE. THE CAPASULS WERE SENT TO PATHOLOGY AND THE IMPLANTS ARE BEING MAINTAINED AT THE SURGERY CENTER FOR THE TIME BEING. PATIENT HAS REQUESTED THAT THE IMPLANTS BE RETURNED TO HER.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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: VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: INVALID DATA. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.