BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    MDR report key: 1210033 · Received October 21, 2008

    Report

    Report Number
    2647580-2008-00600
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    PONCE-USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 10/20/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP HERNIA REPAIR. ACCORDING TO THE REPORTER: THE GRAY SEAL BROKE OFF THE BALLOON AND CAME OFF OF THE TROCAR. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PT. 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 STRUCTURAL BALLOON TROCAR DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE-USS P8G0170

    Patients

    Seq Age Sex Outcome Treatment
    1