BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 29MM, CURVED

    MDR report key: 2983568 · Received February 28, 2013

    Report

    Report Number
    3005075853-2013-00950
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, IT WAS REPORTED BY THE SURGEONS: THE CIRCULAR WAS FIRED TO CREATE THE ANASTAMOSIS. THE DONUTS WERE INSPECTED AND WERE GOOD. THE ANASTAMOSIS WAS LEAK TESTED BY AIR WITH NO BUBBLES. THE PATIENT GOT ILL FIVE DAYS POST OP AFTER FEELING A "POP" IN THE RECTUM. THE PATIENT PRESENTED WITH SEPSIS. THE PATIENT WAS RETURNED TO SURGERY WHERE AN ANTERIOR LATERAL DEFECT WAS FOUND IN THE ANASTAMOSES. THE PATIENT WAS DIVERTED. THE SURGEON DID NOT INDICATE THAT THERE WERE ANY FURTHER COMPLICATIONS. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88233 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention