BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPOINT RESECTOSCOPE SYSTEM

    MDR report key: 2982151 · Received February 18, 2013

    Report

    Report Number
    2982151
    Event Type
    Malfunction
    Date Received
    February 18, 2013
    Date of Event
    August 8, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    JOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US

    Narratives

    Description of Event or Problem · 1

    THE ELECTRODE WOULD NOT SEAT PROPERLY INTO THE MACHINE'S CABLE THEREFORE IT WAS UNABLE TO BE USED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VAGINAL DILATION AND CURETTAGE WITH HYSTEROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70149 VERSAPOINT RESECTOSCOPE SYSTEM HYSTEROSCOPE JOS ETHICON, INC. * MGY0907075

    Patients

    Seq Age Sex Outcome Treatment
    1 *