BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3172912 · Received June 17, 2013

    Report

    Report Number
    3005075853-2013-03068
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 24, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A ECR60D CARTRIDGE RELOAD PRESENT. ADDITIONALLY, THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED AND LEFT SIDE PARTIALLY FIRED 1/2. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. ADDITIONALLY THE CARTRIDGE PAN WAS DETACHED FROM THE CARTRIDGE BODY. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. 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 SLEEVE GASTRECTOMY, ON THE THIRD FIRING OF THE DEVICE USING A GOLD RELOAD; THE FIRING WAS COMPLETED AND THE KNIFE WAS RETURNED TO THE HOME POSITION AND WHEN THE JAWS WERE OPENED THE MIDDLE PORTION, APPROXIMATELY ONE CENTIMETER WAS OPEN; NO STAPLES DEPLOYED. WHEN REMOVING THE GASTRIC REMNANTS, THE PORTION THAT WAS REMOVED FROM THE PATIENT WAS COMPLETELY STAPLED AND SEALED. A SECOND DEVICE WAS OPENED AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. THE SURGEON ENDOSCOPICALLY STITCHED OVER THE STAPLE LINE THAT WAS PREVIOUSLY OPEN FROM THE THIRD FIRING WITH A BOUGIE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272902 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1