BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 60-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 2150480 · Received June 16, 2011

    Report

    Report Number
    2647580-2011-00414
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 10, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLECTOMY FUNCTIONAL END TO END ANASTOMOSIS. ACCORDING TO THE REPORTER: AFTER THE 1ST FIRING, THE RELEASING BUTTON WAS NOT PRESSED, BUT THE DEVICE CAME OFF OF THE TISSUE. STAPLING WAS DONE PROPERLY. THE SURGEON HAD TO RESECT MORE TISSUE THAN WHAT WAS ORIGINALLY PLANNED DUE TO THE PRODUCT PROBLEM. ANOTHER DEVICE WAS USED. NO BLEEDING WAS REPORTED. NOTHING FELL INTO THE PATIENT CAVITY. NO TISSUE DAMAGE WAS REPORTED. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA 60-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL ACCESS DEVICE GDW USSC PUERTO RICO P1B107S

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability