BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACK PROBE

    MDR report key: 52706 · Received November 21, 1996

    Report

    Report Number
    1825883-1996-00007
    Event Type
    Malfunction
    Date Received
    November 21, 1996
    Date of Event
    October 24, 1996
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE PROBE DURING AN ARTHROSCOPIC SURGICAL PROCEDURE. THE TIP OF THE PROBE BROKE. THE TIP WAS RECOVERED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACK PROBE PROBE HRX INSTRUMENT MAKAR, INC. 10016 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other