BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE ENDOSCOPE

    MDR report key: 535608 · Received March 17, 2004

    Report

    Report Number
    1418479-2004-00007
    Event Type
    Malfunction
    Date Received
    March 17, 2004
    Date of Event
    February 17, 2004
    Report Date
    February 18, 2004
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING RIGHT URETEROSCOPY SURGERY, THE SURGEON NOTICED THAT A SMALL METAL OBJECT FELL OUT OF THE FLEXIBLE URETEROSCOPE. THE METAL PIECE WAS RETRIEVED WITH NO PT PROBLEMS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE ENDOSCOPE FLEXIBLE ENDOSCOPE GCQ RICHARD WOLF MEDICAL INSTRUMENTS 7325.172 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR