Description of Event or Problem · 1
ON APRIL 15, 1992, PATIENT WAS ADMITTED TO HOSPITAL BY HIS PHYSICIAN FOR A VIDEOARTHROSCOPY OF HIS LEFT KNEE. ACCORDING TO THE OPERATION REPORT, THE PROCEDURE WENT SMOOTHLY, AND THE PATIENT WAS DISCHARGED HOME THAT EVENING.OVER THE NEXT FIVE WEEKS, THE PATIENT WAS SEEN BY THE PHYSICIAN IN HIS OFFICE WITH CONTINUING COMPLAINTS OF PAIN IN HIS LEFT KNEE. AROUND MAY 18, 1992 AN X-RAY WAS TAKEN OF THE PATIENT'S KNEE, AND A METELLIC FOREIGN BODY WAS NOTED AS BEING PRESSENT. SURGERY WAS SCHEDULE IMMEDIATELY FOR REMOVAL OF THE FOREIGN BODY. A FIVE (5) INCH PIECE OF ARTHROSCOPIC LENS FROM THE PREVIOUS SURGERY WAS REMOVED FROM THE PATIENT'S KNEE IN THE SUPPRAPATELLAR POUCH REGION BETWEEN THE AREA OF THE PATELLA AND THE FEMORAL CONDYLES. THE PROCEDURE WAS TOLERATED WELL AND PATIENT SENT HOME THAT SAME EVENING.DEVICE 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, NONE OR UNKNOWN, OTHER. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.