BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 1082095 · Received July 25, 2008

    Report

    Report Number
    2647580-2008-00417
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 13, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP RADICAL NEPHRECTOMY. ACCORDING TO THE REPORTER: THE BALLOONS ON ALL THREE TROCARS POPPED DURING CASE. SURGEON STATES HE DID NOT USE EXCESSIVE FORCE OR HIT BALLOONS WITH LIGHT SOURCE OR INSTRUMENTATION. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PT. THE OPERATING TIME WAS NOT EXTENDED AS A RESULT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 12MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P7M358

    Patients

    Seq Age Sex Outcome Treatment
    1