BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 CHIP HD CAMERA HEAD

    MDR report key: 3998801 · Received August 4, 2014

    Report

    Report Number
    1418479-2014-00041
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 16, 2014
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) WAS NOTIFIED BY SALES REPRESENTATIVE THAT DURING A PROCEDURE THE QUALITY OF THE PICTURE WENT BAD. THE DEVICE NEEDED TO BE SWAPPED OUT FOR A BACK-UP DEVICE. THIS CAUSED A DELAY IN THE PROCEDURE BEING PERFORMED AND MAY HAVE PUT THE PATIENT AT RISK. NO INJURY TO PATIENT OR STAFF MEMBERS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452678 3 CHIP HD CAMERA HEAD CAMERA HEAD FET RICHARD WOLF GMBH 85525922

    Patients

    Seq Age Sex Outcome Treatment
    1