BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 45-4.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1032861 · Received April 22, 2008

    Report

    Report Number
    2647580-2008-00232
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 2, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SUBMITTED: APRIL 22, 2008.

    Description of Event or Problem · 1

    PROCEDURE: LAP ASSISTED AR. PT SEX: UNK. ACCORDING TO THE REPORTER: AFTER APPROPRIATELY FIRING THE DEVICE AND CHECKING FOR PROPER FIRING, THE SURGEON CUT THE SPECIMEN WITH A SCALPEL USING THE TA4548S AS GUIDE. WHEN THE BLACK RELEASE BUTTON WAS PRESSED TO OPEN THE JAWS, NO STAPLES WERE PLACED ON THE BOWEL. ANOTHER DEVICE WAS USED TO CLOSE THE BOWEL AND THERE WAS NO REPORT OF FURTHER COMPLICATION. THE DEVICE WILL BE RETURNED TO THE MFR FOR FURTHER EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 45-4.8 SINGLE USE RELOADABLE STAPLER SURGICAL STAPLING DEVICE GDW PONCE - USS P6J959

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention