BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER EXTRA VIEW BALLOON - OVAL

    MDR report key: 2112898 · Received May 25, 2011

    Report

    Report Number
    2647580-2011-00366
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K954175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE RPTR: THE BALLOON ON THE OVAL TROCAR BROKE OFF. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PT. NO ADDITIONAL BLEEDING AND NO TISSUE DAMAGE WERE REPORTED. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER EXTRA VIEW BALLOON - OVAL DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1