BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER RELOAD - STANDARD

    MDR report key: 1032242 · Received April 18, 2008

    Report

    Report Number
    1527736-2008-02279
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    February 17, 2008
    Report Date
    March 24, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RECTUM PROCEDURE, WHEN THE INSTRUMENT WAS FIRED, THERE WAS AN INTERRUPTION OF THE RELOAD, BUT THE FIRING WAS COMPLETE. THERE WAS AN AREA THAT ONLY HAD PARTIAL STAPLING. IT WAS NECESSARY TO COMPLETE AN ADDITIONAL FIRING. UNK HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER RELOAD - STANDARD GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4HH1V

    Patients

    Seq Age Sex Outcome Treatment
    1