BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1151471 · Received September 5, 2008

    Report

    Report Number
    2647580-2008-00517
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 14, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: THE CLIENT IS REPORTING THAT THE STAPLES DID NOT HOLD. A RE-OPERATION OF THE PT WAS PERFORMED. NO FURTHER INFO COULD BE OBTAINED FROM THE INITIAL REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA 80-3.8 SINGLE USE RELOADABLE STAPLER SURGICAL STAPLING DEVICE GDW PONCE - USS P8E1052

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention