BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILA 100-3.8 ANASTOMOTIC TITANIUM DLU

    MDR report key: 1030736 · Received April 17, 2008

    Report

    Report Number
    2647580-2008-00227
    Event Type
    Injury
    Date Received
    April 17, 2008
    Report Date
    March 24, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GAG
    PMA / PMN Number
    K885047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: WHEN THE DEVICE WAS FIRED, THE STAPLES DID NOT FORM CORRECTLY. THE TISSUE HAD TO BE RESECTED AND ANOTHER DLU WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILA 100-3.8 ANASTOMOTIC TITANIUM DLU DISPOSABLE STAPLER LOADING UNIT GAG PONCE - USS P7H0118

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention