BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSASTEP PLUS LONG 12MM CANN + DILATOR

    MDR report key: 2881279 · Received November 14, 2012

    Report

    Report Number
    2647580-2012-00715
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K012539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: ROUX-EN-Y. ACCORDING TO THE REPORTER: THE SURGEON COMPLAINED OF AN UNACCEPTABLE DRAG WHEN INSERTING/REMOVING STAPLER FROM TROCAR. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSASTEP PLUS LONG 12MM CANN + DILATOR DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1