BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** LINEAR CUTTER RELOAD

    MDR report key: 1881011 · Received October 25, 2010

    Report

    Report Number
    3005075853-2010-06028
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RETURN THE ANALYSIS RESULTS FOUND THAT THE RELOAD WAS RECEIVED IN GOOD VISUAL CONDITION AND FULLY FIRED. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE RELOAD. EVENT COULD NOT BE CONFIRMED AS NO INSTRUMENT WAS RECEIVED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT HEMI COLECTOMY PROCEDURE, THE FIRST TWO FIRINGS WERE FINE. ON THE THIRD FIRING, THE DEVICE MISFIRED AT THE 'CROTCH' OF THE RELOAD. THE OPEN PART OF THE STAPLE LINE WAS HAND SEWED CLOSED. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    A GAS LEAK WAS NOTED DURING USE OF THE MOCELLATOR. ATTEMPTED USE OF SEVERAL ADAPTORS, WITH SAME RESULT. A SECOND MORCELLATOR WAS OPENED, AND SAME PROBLEM WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** LINEAR CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. G4TG41

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE