BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 2011763 · Received February 14, 2011

    Report

    Report Number
    2647580-2011-00093
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    November 24, 2010
    Report Date
    January 19, 2011
    Manufacturer
    USSC PUERTO RICO, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: THE TROCAR SEEMS LEAK, AND BALLOON WOULD NOT INFLATE CORRECTLY. NO ADDITIONAL 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 PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER PREPERITONEAL DIST BALLOON DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1