BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1241708 · Received November 19, 2008

    Report

    Report Number
    2647580-2008-00650
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 24, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: BOWEL RESECTION. ACCORDING TO THE REPORTER: THE INSTRUMENT APPLIED CORRECTLY THE FIRST AND SECOND TIME BUT ON THE THIRD FIRING, BLEEDING WAS OBSERVED AT THE STAPLE LINE. THE SURGEON OVERSEWED THE LINE BUT BLEEDING WAS STILL PRESENT. A SECOND ANASTOMOSIS WAS PERFORMED BUT STILL SOME BLEEDING WAS OBSERVED. THE SURGEON OVERSEWED AND THEN CLOSED WITH A TA INSTRUMENT. THE BLEEDING WAS REPORTED TO BE LESS THAN 250CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA 80-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW PONCE - USS P8H0374

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention