BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 2133273 · Received May 11, 2011

    Report

    Report Number
    2647580-2011-00310
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPARO KIDNEY SURGERY. ACCORDING TO THE REPORTER: DURING THE CASE AFTER PUMPING THE BALLOON 30 TIMES, WHEN THE SCOPE WAS INSERTED THE BALLOON BURST. THE FALLEN PIECES WERE RETRIEVED. USED OTHER DEVICE. NO BLEEDING. NO TISSUE DAMAGE. NOT EXTENDED MORE THAN 30 MINUTES. NO PT INFO AVAILABLE. NO PT 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 P0K0980

    Patients

    Seq Age Sex Outcome Treatment
    1