BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 1082098 · Received July 25, 2008

    Report

    Report Number
    2647580-2008-00419
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 29, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP. NEPHRECTOMY. ACCORDING TO THE REPORTER: DR TRIED TO USE A BLUNT TIP TROCAR FOR LAP. NEPHRECTOMY BUT THE BALLOON BURSTED DURING THE PROCEDURE, ALL PIECES WERE RETRIEVED. THE OPERATING TIME AND THE INCISION WERE NOT EXTENDED AS A RESULT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY WAS REPORTED. PT IS FINE AND LEFT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 10MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P7L0753

    Patients

    Seq Age Sex Outcome Treatment
    1