BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 1210040 · Received October 21, 2008

    Report

    Report Number
    2647580-2008-00605
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 17, 2008
    Manufacturer
    PONCE- USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 10/21/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: VARICOSE VEINS OF LEGS / SUBFASCIAL ENDOSCOPIC PERFORATOR SURGERY. ACCORDING TO THE REPORTER: INSERTED THE TROCAR INTO THE CAVITY AND TRIED TO PLACE IT THERE, THEN A PLASTIC PART DISENGAGED FROM NEAR THE LATCH. HOWEVER, THE TROCAR WORKED PROPERLY DURING THE PROCEDURE. NO TISSUE DAMAGE. NO BLEEDING. NOTHING FELL INTO THE CAVITY. EXTENDED OR TIME: UNK. NO PT INJURY WAS REPORTED. PT STATUS: OK. NO FURTHER PT INFO AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1