BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 929297 · Received October 16, 2007

    Report

    Report Number
    2647580-2007-00512
    Event Type
    Malfunction
    Date Received
    October 16, 2007
    Date of Event
    September 4, 2007
    Report Date
    September 26, 2007
    Manufacturer
    PONCE-USS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 10/16/2007.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP DONOR NEPHRECTOMY. ACCORDING TO THE REPORTER: THE BALLOON EXPLODED DURING USE. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PT. 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 AND THE PT IS IN WELL CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR