BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM 44CM SHAFT

    MDR report key: 3973789 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05433
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    May 2, 2014
    Report Date
    June 2, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: RELEASE BUTTON SPRING. THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED WITH NO CARTRIDGE RELOAD PRESENT. AFTER FURTHER ANALYSIS, IT WAS NOTED THE DEVICE CLAMPING MECHANISM WAS NOTED TO BE DAMAGED. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE DISTAL SPRING CLAMP RELEASE WAS NOTED TO BE OUT OF POSITION THUS, THE RELEASE BUTTON REMAINS FORWARD AND IT DID NOT ENGAGED WITH THE CLAMP ARM. THIS CONDITION CAUSED THE DEVICE WON¿T LOCK IN THE CLOSED POSITION. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. ALTHOUGH NO CONCLUSION COULD BE REACHED ON WHAT MAY HAVE CAUSED THE FOUND CONDITION OF THE SPRING CLAMP RELEASE TO BE OUT OF ITS INTENDED POSITION, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, THE DEVICE WOULD NOT FIRE AFTER THREE USES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450271 PWRD ECH FLEX 60MM 44CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1