BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK TIP COAGULATOR

    MDR report key: 278431 · Received May 19, 2000

    Report

    Report Number
    1825883-2000-00001
    Event Type
    Malfunction
    Date Received
    May 19, 2000
    Date of Event
    October 21, 1999
    Report Date
    January 27, 2000
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOTED AT THE END OF ARTHROSCOPIC PROCEDURE THAT THE TIP OF THE COAGULATOR ELECTRODE WAS MISSING. SURGICAL REMOVAL OF THE TIP DONE THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOOK TIP COAGULATOR ELECTROSURGICAL COAGULATOR ELECTRODE GEI INSTRUMENT MAKAR, INC. 10798 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other