BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSASTEP PLUS 11MM CANN/DILT W/RADEXPSLV

    MDR report key: 3932263 · Received April 4, 2014

    Report

    Report Number
    9612501-2014-00089
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K012539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE PORT CAME APART AND BROKE. NO OTHER INFORMATION PROVIDED OVER THE PHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205631 VERSASTEP PLUS 11MM CANN/DILT W/RADEXPSLV DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN J3F0140X

    Patients

    Seq Age Sex Outcome Treatment
    1