BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILA 100-3.8 ANASTOMOTIC TITANIUM DLU

    MDR report key: 2021606 · Received March 10, 2011

    Report

    Report Number
    2647580-2011-00161
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 1, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    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

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LADG - LAP ASSISTED DISTAL GASTRECTOMY. ACCORDING TO THE REPORTER: AFTER THE DUODENUM WAS CUT, THE STOMACH WAS TAKEN OUT, THE DEVICE'S PLASTIC KNOB WAS PRESSED, BUT ONLY STAPLING WAS DONE. THE DEVICE DID NOT CUT. ADDITIONAL RESECTION AND MANUAL SUTURING WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILA 100-3.8 ANASTOMOTIC TITANIUM DLU SURGICAL STAPLER GDW USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability