BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 1081880 · Received July 21, 2008

    Report

    Report Number
    2647580-2008-00405
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 24, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 07/21/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE RPTR: WHILE TRYING TO POSITION THE INSTRUMENT, A PART DISENGAGED FROM LOCKING LATCH. IT DID NOT FALL INTO THE CAVITY. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY. 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. PT STATUS: OK. NO FURTHER PT INFO AVAILABLE.

    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