BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 147045 · Received January 2, 1998

    Report

    Report Number
    147045
    Event Type
    Malfunction
    Date Received
    January 2, 1998
    Date of Event
    August 5, 1997
    Report Date
    August 13, 1997
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING OPERATIVE PROCEDURE (ARTHROTOMY R KNEE) THE HOOK TIP FOR HAND HELD COAGULATOR BROKE OFF & EMBEDDED IN PT TISSUE. X-RAYS DONE & TIP RETRIEVED BUT OPERATIVE PROCEDURE EXTENDED BY HOOK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other