BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 1193183 · Received October 7, 2008

    Report

    Report Number
    2647580-2008-00585
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 23, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 10/07/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP HERNIA REPAIR. ACCORDING TO THE REPORTER: THE BALLOON BROKE DURING THE CASE, NO PIECE OF DEVICE REPORTED FALLING INTO PATIENT CAVITY. NO DELAY IN OR REPORTED. 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 BLUNT TIP TROCAR 10MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS

    Patients

    Seq Age Sex Outcome Treatment
    1