BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 60-4.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1020666 · Received March 27, 2008

    Report

    Report Number
    2647580-2008-00183
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 14, 2008
    Report Date
    March 3, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GAG
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    TYPE OF PROCEDURE: LAR. ACCORDING TO THE REPORTER: AFTER THE DST TA 60-4.8 FIRED IN THE RECTUM, THE STAPLES WERE MALFORMED AND CAUSED RECTUM STUMP LEAKAGE. ANOTHER STAPLER OF THE SAME MODEL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO REPORT OF FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 60-4.8 SINGLE USE RELOADABLE STAPLER SURGICAL STAPLER DEVICE GAG PONCE - USS P7E0649

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention