BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MAKAR

    MDR report key: 225611 · Received May 26, 1999

    Report

    Report Number
    1825883-1999-00001
    Event Type
    Malfunction
    Date Received
    May 26, 1999
    Date of Event
    March 2, 1999
    Report Date
    May 25, 1999
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF INSTRUMENT BROKE OFF IN PT KNEE. INCISION WAS EXTENDED TO RETRIEVE BROKEN TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTRUMENT MAKAR MINI GRASPER GEN INSTRUMENT MAKAR, INC. 10055 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention