BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHEATH

    MDR report key: 4208955 · Received October 20, 2014

    Report

    Report Number
    1418479-2014-00046
    Event Type
    Malfunction
    Date Received
    October 20, 2014
    Date of Event
    July 29, 2014
    Report Date
    September 26, 2014
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED A MEDWATCH REPORT ON (B)(6) 2014. REPORT INDICATED CERAMIC TIP OF DEVICE BROKE DURING A HYSTEROSCOPY PROCEDURE. PIECES FELL IN PATIENT'S UTERUS AND WERE RETRIEVED FROM UTERUS BY IRRIGATION/FLUSHING WITH SALINE. NO RADIOGRAPHS WERE OBTAINED. NO INJURY TO PATIENT OR STAFF REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666722 SHEATH GCJ RICHARD WOLF GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR