BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYSTEROSCOPIC RECIPROCATING MORCELLATOR

    MDR report key: 2100925 · Received May 19, 2011

    Report

    Report Number
    MW5020673
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 13, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING HYSTEROSCOPIC MYOMECTOMY USING A MORCELLATOR. USING THE LARGER RECIPROCATING PORT OF THE MORCELLATOR THE DISTAL FIBROID WAS REMOVED. HOWEVER DURING THE REMOVAL OF THE PROXIMAL FIBROID THE ATTACHMENT PIECE SNAPPED AND BROKE. THE SMALL POLYP HANDLE WAS USED HOWEVER THE FLUID DEFICIT INCREASED AND THE HYSTEROSCOPIC MYOMECTOMY WAS ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYSTEROSCOPIC RECIPROCATING MORCELLATOR HYSTEROSCOPIC RECIPROCATING MORCELLATOR GCJ SMITH & NEPHEW, INC. 759143

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR