BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3107639 · Received May 10, 2013

    Report

    Report Number
    3005075853-2013-02235
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    March 30, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: WHAT DEVICE WAS USED WITH THIS RELOAD? PLE 60 A. DID THE DEVICE CUT? YES. DID THE DEVICE STAPLE? NO. THE ANALYSIS RESULTS SHOWED THAT ONE ECR60T RELOAD WAS RECEIVED IN GOOD CONDITION, FULLY LOADED WITH STAPLES, AND WITH THE ONE PIECE SLED ADVANCED; HOWEVER, IT HAD NOT BEEN LOCKED OUT. THE RETURNED RELOAD WAS LOADED INTO A TEST DEVICE FOR FUNCTIONAL TESTING. THE DEVICE ACHIEVED ITS COMPLETE STROKE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE THE CARTRIDGE MISFIRED. NO PATIENT CONSEQUENCES REPORTED. ONE RELOAD WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207378 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CM9X

    Patients

    Seq Age Sex Outcome Treatment
    1