BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILA 52 ANASTOMOTIC TITANIUM DLU

    MDR report key: 1020502 · Received March 28, 2008

    Report

    Report Number
    2647580-2008-00185
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 28, 2008
    Manufacturer
    PONCE -USS
    Product Code
    GAG
    PMA / PMN Number
    K885047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: WHEN FIRING ACROSS THE DUODENUM, THE KNIFE BLADE ADVANCED PROPERLY BUT THE STAPLES DID NOT FORM ON THE TISSUE. ANOTHER DEVICE WAS USED TO CLOSE THE INCOMPLETE STAPLE LINE. THERE WAS A TEN MIN DELAY IN OR TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILA 52 ANASTOMOTIC TITANIUM DLU DISPOSABLE LOADING UNIT GAG PONCE -USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention