BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK TIP COAGULATOR

    MDR report key: 287073 · Received July 21, 2000

    Report

    Report Number
    1825883-2000-00002
    Event Type
    Malfunction
    Date Received
    July 21, 2000
    Date of Event
    June 20, 2000
    Report Date
    June 23, 2000
    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

    DURING SURGERY SURGEON WAS USING HAND-HELD HOOK TIP COAGULATOR TO COAGULATE BLEEDERS AND WHEN IT WAS PULLED OUT OF THE PUNCTURE WOUND THE TIP OF THE COAGULATOR ELECTRODE BROKE OFF INSIDE THE KNEE. THE BROKEN TIP WAS RETRIEVED LATER.

    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 * Required Intervention