BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3071509 · Received April 22, 2013

    Report

    Report Number
    3005075853-2013-01919
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 1, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE, DAMAGED DRIVERS, DAMAGED MOTOR, DAMAGED ONE PIECE SLED. THE DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR60B LOADED INTO THE DEVICE. FURTHERMORE, THE RELOAD WAS NOTED TO BE FULLY FIRED ON THE RIGHT SIDE, ON THE LEFT SIDE THE OUTER LINE WAS FULLY FIRED AND THE 2 INNER ROWS WERE PARTIALLY FIRED 1/8. ONCE THE PAN WAS REMOVED FROM THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED DAMAGED. NO EVIDENCE OF DAMAGE ON THE CARTRIDGE DECK WAS FOUND. UPON EVALUATION, THE DEVICE WAS NOTED TO BE NON FUNCTIONAL. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED AND THE MOTOR WAS FOUND DAMAGED. PLEASE NOTE THAT 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: PLEASE FIND THE BELOW RESPONSES: DID THE DEVICE CUT WITH THIS RELOAD? YES, THE STAPLER CUT THE TISSUE. . DID THE DEVICE STAPLE WITH THIS RELOAD? NO, THE STAPLE DID FORMED WITH THIS RELOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE CARTRIDGE MISFIRED. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171114 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60B-J4CP30, J4CM2G