BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 1082102 · Received July 25, 2008

    Report

    Report Number
    2647580-2008-00420
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Report Date
    July 1, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THIS INCIDENT OCCURRED AT THE VERY START OF THE CASE. THE PORT HAD A SMALL METAL PIECE INSIDE OF IT THAT IS THE SIZE OF THE LEAD IN A PENCIL AND ONLY ABOUT 4MM LONG. THE SHAFT OF THE PORT WAS BROKEN AND THE PIECE WAS FOUND ON THE ABDOMINAL WALL, HOWEVER, IT DID NOT FALL INSIDE THE PT. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PT. NO PT 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 P7J05090

    Patients

    Seq Age Sex Outcome Treatment
    1