BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-4.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 2020196 · Received March 7, 2011

    Report

    Report Number
    2647580-2011-00152
    Event Type
    Injury
    Date Received
    March 7, 2011
    Report Date
    February 9, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOID RESECTION. ACCORDING TO THE REPORTER: APPROXIMATELY 1/2" OF THE STAPLE LINE WAS MALFORMED. THIS MALFORMED AREA OF THE STAPLE LINE WAS RESECTED AND A NEW STAPLE LINE WAS FORMED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. UNANTICIPATED TISSUE LOSS OCCURRED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA 80-4.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P0H1137R

    Patients

    Seq Age Sex Outcome Treatment
    1