BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITE RELOAD

    MDR report key: 1931026 · Received December 17, 2010

    Report

    Report Number
    3005075853-2010-07223
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    December 30, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE SENT UPON RECEIPT OF FURTHER INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION. THE PATIENT IS DOING FINE. THE SURGEON HAS BEEN IN-SERVICED ON ALL DEVICES. NO ANOMALIES WERE REPORTED AT THE INITIAL SURGERY.

    Description of Event or Problem · 1

    THE RPTR STATED THAT THE PT HAD A SURGICAL PROCEDURE USING THE ADVANSYS MID FOOT PLATING SYSTEM: MEDIAL LISFRANC PLATE - (PRODUCT CATALOG NUMBER NOT PROVIDED TO DATE) ON (B)(6) 2010. THE SECOND SURGERY IS PLANNED ON (B)(6) 2010 FOR DEVICE REMOVAL AND TENDON PLASTY. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFORMATION FROM THE RPTR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE THE DEVICE FIRED FINE AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THAT EVENING THE PATIENT WAS BROUGHT BACK INTO THE OPERATING ROOM DUE TO LOW HEMOGLOBIN. THE SURGEON OPENED THE PATIENT AND THERE WAS A LOT OF CLOTTING WHERE THE WHITE CARTRIDGE WAS FIRST FIRED AT THE MESENTERY OF THE JEJUNUM NEAR THE LIGAMENT OF TREITZ. BLEEDING HAD OCCURRED, BUT BY THE TIME THE SURGEON OPENED THE PATIENT THE BLEEDING HAD STOPPED. IT IS UNKNOWN THE AMOUNT OF BLOOD LOSS. THE SURGEON CLOSED THE PATIENT AND THE PATIENT RECEIVED FOUR UNITS OF BLOOD TO STABILIZE THE PATIENT. THE PATIENT IS STABLE AND DOING WELL. THE DEVICE WAS USED TO COMPLETE THE CASE AND THEN DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention