BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE ACCESSORY KIT,4ARM

    MDR report key: 7964798 · Received October 15, 2018

    Report

    Report Number
    7964798
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 26, 2018
    Report Date
    September 29, 2018
    Manufacturer
    MICROTEK MEDICAL, INC
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CAMERA DRAPE WOULD NOT CONNECT AND LOCK ON CAMERA HEAD. SEVERAL ATTEMPTS WERE MADE BY DIFFERENT STAFF MEMBERS. A NEW DRAPE WAS OPENED. CONNECTION AND LOCKING CAMERA HEAD WAS MADE WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807172 DISPOSABLE ACCESSORY KIT,4ARM DRAPE, SURGICAL, ACCESSORY KKX MICROTEK MEDICAL, INC 420291 D181647

    Patients

    Seq Age Sex Outcome Treatment
    1