BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 4802133 · Received May 28, 2015

    Report

    Report Number
    3005075853-2015-03257
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    April 30, 2015
    Report Date
    April 30, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH NO RELOAD PRESENT. THE FIRING TRIGGER WAS NOTED TO BE JAMMED HALFWAY BLOCKING THE CLOSING TRIGGER TO HOME POSITION. THEREFORE, THE DEVICE WOULD NOT OPEN. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH AND PINION AXLE SUPPORT WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACHED ON WHAT CAUSED THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO FIRE ON THICKER TISSUE THAN INDICATED OR ATTEMPTED TO FIRE TROUGH A LOCKED RELOAD IN PREVIOUS FIRINGS CAUSING AN INCREASE OF THE INTERNAL FORCES RESULTING IN THE COMPONENT YIELDING. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUX-EN-Y GASTRIC BYPASS PROCEDURE, WHILE CREATING THE STOMACH POUCH, HE USED THE DEVICE WITH A BLUE RELOAD. THREE RELOADS WERE FIRED CORRECTLY WHILE THE FORTH ONE WAS STUCK AND IT WAS ALMOST IMPOSSIBLE TO OPEN IT IN ORDER TO TAKE ANOTHER STEP. THE DEVICE WAS REPLACED WITH A NEW GUN AND AGAIN, TWO RELOADS WERE FIRED CORRECTLY AND THE THIRD ONE WAS STUCK AGAIN. THE SAME SITUATION REPEATED AND THE DOCTOR ASKED FOR A THIRD LIKE DEVICE. A THIRD LIKE WAS USED TO COMPLETE THE PROCEDURE. THE CASE WAS DELAYED BY TWENTY-FIVE MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345399 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK M4H81E

    Patients

    Seq Age Sex Outcome Treatment
    1