BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 2634276 · Received June 25, 2012

    Report

    Report Number
    2647580-2012-00387
    Event Type
    Injury
    Date Received
    June 25, 2012
    Date of Event
    June 4, 2012
    Report Date
    June 4, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: RESECTION. ACCORDING TO THE RPTR: THE (B)(4) DEVICE WAS CONNECTED. THE DEVICE DISPLAYED GREEN AND COULD NOT BE FIRED CORRECTLY. THE CLAMPS WERE FORMED TO AN U. RE-SECTION WAS REQUIRED. DISTAL MANUALLY CLOSED AND AGAIN ANASTOMOSIS WITH (B)(4) . SURGERY TIME WAS EXTENDED BY MORE THAN 30 MINS. A NEW INSTRUMENT HAD TO BE USED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P1M0179X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other