BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREEN RELOAD

    MDR report key: 1850489 · Received October 1, 2010

    Report

    Report Number
    3005075853-2010-05641
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 7, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LAPAROSCOPIC GASTRIC PROCEDURE WAS PERFORMED ON (B)(6)2010 AND THE PROCEDURE WENT WELL. THE STAPLES WERE FORMED PROPERLY AND A LEAK TEST WAS PERFORMED DURING THE PROCEDURE. TWO DAYS POST OP, THE PATIENT RETURNED TO THE ER EXHIBITING SOME PROBLEMS. THE PATIENT WAS TAKEN IN FOR SOME DIAGNOSTIC TESTING, AND IT WAS FOUND THAT THE STAPLE LINE AT THE FUNDUS OF THE STOMACH WAS LEAKING. THE PATIENT WAS TAKEN BACK INTO THE OR AND SUTURES WERE USED TO COMPLETE THE STAPLE LINE LEAK. THE PATIENT IS STILL IN THE HOSPITAL AT THIS TIME AND STABLE. ADDITIONAL FOLLOWUP: THE PATIENT'S SYMPTOMS WERE ABDOMINAL PAIN. THE LEAK WAS IDENTIFIED BY CT SCAN WITH BARIUM SWALLOW. THE PATIENT RECEIVED ANTIBIOTICS AND THERE WAS NO BLOOD TRANSFUSION NEEDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention