BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 1121981 · Received August 13, 2008

    Report

    Report Number
    2647580-2008-00467
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 18, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 08/13/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LEFT RENAL CRYO LAP. ACCORDING TO THE REPORTER: THE BALLOON WAS OVER INFLATED TO 30+ CCS., AT THAT POINT, THE BALLOON BURST WHILE INSIDE THE CAVITY. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY. OPERATING ROOM TIME WAS EXTENDED APPROXIMATELY 20 MINUTES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 12MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS

    Patients

    Seq Age Sex Outcome Treatment
    1