BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** LINEAR CUTTER RELOAD - STANDARD

    MDR report key: 2973000 · Received February 21, 2013

    Report

    Report Number
    3005075853-2013-00793
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 31, 2012
    Report Date
    February 4, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLES WERE MALFORMED AFTER THE FIRING. THE SURGEON USED HAND SEWING TO PIN UP THE TISSUE AND COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76063 PROXIMATE** LINEAR CUTTER RELOAD - STANDARD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1