BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 29MM, CURVED

    MDR report key: 2862402 · Received December 10, 2012

    Report

    Report Number
    3005075853-2012-05516
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 16, 2012
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP LOW ANTERIOR RESECTION PROCEDURE, PER THE SURGEON: PATIENT HAD A LOT OF CLOTS AND BLOOD WHEN A RECTAL EXAMINATION WAS PERFORMED. THERE WAS A DROP IN THE HEMOGLOBIN LEVEL ALSO. BLEEDING WAS NOTICED POST-OP AND STAPLE LINE WAS PACKED WITH GEL FOAM AND EPINEPHRINE. NO NEED TO GO BACK IN LAPAROSCOPICALLY. THE BLEEDING WAS TAKEN CARE OF POST-OP TRANSANALLY. THERE WERE NO OTHER REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H44U26

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention