BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYSTEROSCOPE AND ACCESSORIES

    MDR report key: 6922229 · Received October 6, 2017

    Report

    Report Number
    6922229
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    September 11, 2017
    Report Date
    September 12, 2017
    Manufacturer
    KARL STORZ
    Product Code
    NWW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WAS USING THE CUTTING LOOP AND THE LOOP BROKE IN HALF. THE SURGEON REQUESTED A NEW CUTTING LOOP. THE PATIENT WAS NOT INJURED AND NO PIECES WERE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702758 HYSTEROSCOPE AND ACCESSORIES NWW KARL STORZ 27050G-S

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR