BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3211795 · Received July 8, 2013

    Report

    Report Number
    3005075853-2013-03416
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60G CARTRIDGE RELOAD PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED. THE CARTRIDGE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND NO ABNORMALITIES WERE FOUND. 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 EVENT COULD NOT BE CONFIRMED AS NO MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. A SURGICAL PHOTOGRAPH WAS RECEIVED, BUT IT COULD NOT BE DETERMINED WHAT CAUSED THE COMPLICATION BASED ON THE IMAGE. HOWEVER, COUPLED WITH THE EVENT DESCRIPTION A POTENTIAL CAUSE MAY BE SOME FORM OF STAPLE CARTRIDGE DECK DEFLECTION WHICH TYPICALLY DOES NOT SHOW UP IN PHOTOGRAPHS OF THE STAPLE CARTRIDGE OR DEVICE. THIS TYPE OF COMPLICATION TYPICALLY REQUIRES CLEAR VIEWS OF THE STAPLE LINES AND STAPLE FORMATIONS TO BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, ON THE SECOND FIRING USING A GREEN RELOAD, THE SURGEON CLOSED DOWN ON THE TISSUE AND WAITED THE FIFTEEN SECONDS AND FIRED THE DEVICE. ON THE REMNANT SIDE OF THE CUT LINE THE STAPLES DEPLOYED AND WERE FORMED AS INTENDED. ON THE PATIENT SIDE THE STAPLES WERE MALFORMED AND WERE ¿GOAL POST¿ SHAPED. THERE WAS BLEEDING AND THE SURGEON OVER-SEWED TO COMPLETE THE CASE. THE SURGERY WAS EXTENDED BY TWENTY MINUTES. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION. THE AMOUNT OF BLOOD LOSS IS UNKNOWN. THE DEVICE WAS NOT FIRED OVER AN EXISTING STAPLE LINE OR CLIP AND BUTTRESSING MATERIAL WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311276 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G