BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    MDR report key: 4092765 · Received September 9, 2014

    Report

    Report Number
    2647580-2014-00759
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Report Date
    August 18, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DOCTOR PUT MESH THROUGH TROCAR. AS HE FED IT THROUGH THE GASKET CAME OFF IN THE PATIENT. USED ANOTHER TROCAR. HAD TO PUT ANOTHER TROCAR IN PATIENT TO REMOVE GASKET THAT WAS IN PATIENT. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. THERE WAS A DELAY OVER 30 MINUTES; DELAYED BY 40 MINUTES. ADDITIONAL INFORMATION REQUESTED VIA EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551702 SPACEMAKER STRUCTURAL BALLOON TROCAR SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1