BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA30-V3S STAPLER

    MDR report key: 1080495 · Received July 22, 2008

    Report

    Report Number
    2647580-2008-00409
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 24, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GAG
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A HEPATECTOMY, THE DEVICE WAS FIRED ON THE HEPATIC VEIN BUT STAPLES IN THE CENTER OF STAPLE LINE WERE NOT PLACED. THIS WAS NOTICED AFTER THE VEIN WAS CUT. MORE THAN 500 CC BLEEDING WAS OBSERVED. THE TISSUE WAS TREATED BY HAND SEWING. NO FURTHER DEVICE COMPLICATION OR PT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA30-V3S STAPLER STAPLING DEVICE GAG PONCE - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention