BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 1082108 · Received July 25, 2008

    Report

    Report Number
    2647580-2008-00413
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 26, 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

    Description of Event or Problem · 1

    PROCEDURE TYPE: PROSTATECTOMY. ACCORDING TO THE REPORTER: DURING A PROSTATECTOMY, THE BALLOON BROKE, A PIECE FELL INTO THE CAVITY AND IT WAS RETRIEVED IMMEDIATELY. 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