BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE, MONOPOLAR OPTIMA

    MDR report key: 472826 · Received July 1, 2003

    Report

    Report Number
    2124979-2003-00013
    Event Type
    Malfunction
    Date Received
    July 1, 2003
    Date of Event
    February 11, 2003
    Report Date
    June 30, 2003
    Manufacturer
    ACMI CORPORATION
    Product Code
    HFG
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WHILE SURGEON WAS USING L-HOOK ON CHOLECYSTECTOMY PROCEDURE, A SMOKEY ODOR WAS NOTICED AND THE END OF THE CABLE NEAR THE L-HOOK BROKE COMPLETELY APART. NO INJURY TO PT OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CABLE, MONOPOLAR OPTIMA * HFG ACMI CORPORATION 006358-901 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1