BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER EXTRA VIEW BALLOON - OVAL

    MDR report key: 1962928 · Received December 22, 2010

    Report

    Report Number
    2647580-2010-00995
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    October 23, 2010
    Report Date
    November 26, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K954175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: THE BALLOON DID NOT INFLATE WHEN INSERTED IN TO THE ABDOMEN. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PT. NO ADD'L BLEEDING AND NO TISSUE DAMAGE WERE REPORTED. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. 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 P0G0403

    Patients

    Seq Age Sex Outcome Treatment
    1