BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM SHORT SECONDARY PORT

    MDR report key: 3070955 · Received April 1, 2013

    Report

    Report Number
    2647580-2013-00179
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE BOTTOM EXPANDING FLANGE ON THE PEDIPORT SEPARATED FROM THE MAIN TROCAR WHEN THE SURGEON TWISTED THE LOCKING MECHANISM. THE PART OF THE TROCAR THAT BROKE OFF WAS REMOVED FROM THE PELVIS AND THE OPERATION WAS COMPLETED. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131292 5.5MM SHORT SECONDARY PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY USSC

    Patients

    Seq Age Sex Outcome Treatment
    1