BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 2132234 · Received June 14, 2011

    Report

    Report Number
    2647580-2011-00395
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 1, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: ILEOCECAL RESECTION. ACCORDING TO THE REPORTER: ON THE 2ND FIRING, THE HANDLE WAS STUCK IN THE MIDDLE. IT WAS FORCED SQUEEZED. THE RELEASING HANDLE WAS ALSO STUCK. THE BLACK BUTTON WAS PRESSED AND RELEASED THE DEVICE. THE SURGEON HAD TO RESECT MORE TISSUE THAN WHAT WAS ORIGINALLY PLANNED DUE TO THE PRODUCT PROBLEM. ADDITIONAL STAPLING WAS DONE WITH ANOTHER DEVICE RIGHT UNDER THE 2ND STAPLING LINE. NO UNANTICIPATED BLEEDING OCCURRED. NOTHING FELL INTO THE PATIENT CAVITY. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA 80-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P1A0754

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability GIA 80-3.8 SINGLE USE LOADING UNIT, (B)(4),| KNOWN LOT NUMBER AND EXPIRATION DATE