BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK TIP COAGULATOR

    MDR report key: 69941 · Received February 10, 1997

    Report

    Report Number
    1825883-1997-00001
    Event Type
    Malfunction
    Date Received
    February 10, 1997
    Date of Event
    November 15, 1996
    Report Date
    February 8, 1997
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COAGULATOR WORKED WELL ON THE "COAG" BUTTON WAS PUSHED. WHEN THE "CUT" BUTTON WAS PUSHED, THE ALARM IN THE ELECTOCLAURITY MACHINE WENT OFF. THEY WENT BACK TO "COAG" AND IT WORKED FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN