BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7694

    MDR report key: 7694 · Received January 6, 1994

    Report

    Report Number
    7694
    Event Type
    Injury
    Date Received
    January 6, 1994
    Date of Event
    February 4, 1993
    Report Date
    April 15, 1993
    Manufacturer
    OLYMPUS BNC COAXIAL CABLE
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    67 YEAR OLD PATIENT ADMITTED FOR LAP CHOLY ON 2/4/93. LAP CHOLE CONVERTED TO OPEN DUE TO UNSEATED CABLE FOUND ON ONE SYSTEM AND DEFECTIVE BNC CABLE FOUND ON ANOTHER. PROCEDURE COVERTED TO OPEN DUE TO POOR VISUALIZATION AND GLARE,? CAUSE.PATIENT DISCHARGED SEVERAL DAYS LATER WITHOUT FURTHER COMPLICATIONS.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, ELECTRICAL TESTS PERFORMED. RESULTS OF EVALUATION: ELECTRICAL PROBLEM. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS BNC COAXIAL CABLE N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention