BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORECELLATOR

    MDR report key: 385767 · Received March 29, 2002

    Report

    Report Number
    2210968-2002-00216
    Event Type
    Malfunction
    Date Received
    March 29, 2002
    Date of Event
    March 1, 2002
    Report Date
    March 5, 2002
    Manufacturer
    MEDSOURCE TECHNOLOGIES
    Product Code
    HFG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPARASCOPIC FIBROID REMOVAL, THE DEVICE WOULD NOT MORCELLATE WHEN ACTIVATED. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE X-TRACT MORECELLATOR MORCELLATOR HFG MEDSOURCE TECHNOLOGIES NA MS100105

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN