BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3132155 · Received May 29, 2013

    Report

    Report Number
    3005075853-2013-02588
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ONE PIECE SLED, DAMAGED DRIVERS, DAMAGED CARTRIDGE THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60T RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, LEFT SIDE OUTER ROW FULLY FIRED AND THE LEFT TWO INNER ROWS PARTIALLY FIRED. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. AS ADDITIONAL TESTING, THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE, THE DEVICE DID NOT STAPLE COMPLETELY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETELY. NO PATIENT CONSEQUENCES WERE REPORTED. THIS IS ALL THE INFORMATION AVAILABLE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236850 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1