BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2923877 · Received January 22, 2013

    Report

    Report Number
    3005075853-2013-00289
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    November 19, 2012
    Report Date
    December 3, 2012
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED RELEASE BUTTON. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE?- STOMACH, LOWER TO MIDDLE PORTION. WHAT COLOR CARTRIDGE WAS BEING USED?- GOLD. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? - GREEN. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? -NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP?- YES. A STAPLE LINE. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN?- NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)?- NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION?- NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES. THE ANALYSIS FOUND THAT ONE DEVICE WAS RECEIVED WITHOUT A RELOAD PRESENT AND WITH THE CLAMPING MECHANISM DAMAGED. THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE DEVICE CLOSED, CYCLED AND OPENED WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS. UPON DISASSEMBLING, THE CLAMP ARM WAS NOTED TO BE WORN OUT; IT APPEARS THAT THE DEVICE WAS FORCED OPEN WHEN THE KNIFE WAS NOT ON THE HOME POSITION. THE EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE RELOAD WAS RETURNED FOR ANALYSIS. PLEASE NOTE IF THE INSTRUMENT IS PARTIALLY FIRED, SLIDE THE KNIFE REVERSE SWITCH FORWARD TO RETURN THE KNIFE TO HOME POSITION. TO OPEN THE JAWS, SQUEEZE THE CLOSING TRIGGER, AND THEN SIMULTANEOUSLY PRESS THE ANVIL RELEASE SWITCH ON EITHER SIDE OF THE INSTRUMENT. WHILE PRESSURE IS STILL ON THE ANVIL RELEASE SWITCH, SLOWLY RELEASE THE CLOSING TRIGGER. 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 THE SLEEVE GASTRECTOMY, THE STAPLER COMPLETED TWO FIRINGS PERFECTLY. THE STAPLER LOCKED UP ON THE THIRD FIRING. NEW STAPLER WAS OPENED AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30226 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4C256

    Patients

    Seq Age Sex Outcome Treatment
    1