BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 3960954 · Received May 23, 2014

    Report

    Report Number
    2647580-2014-00377
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 25, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT SENT: MAY 23, 2014.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: TODAY WE USED A OMS-T10BT TROCAR AND IT WOULD NOT ALLOW THE SYRINGE TO BLOW UP THE BALLOON. THE SURGEON TRIED TO REAPPLY THE SYRINGE SEVERAL TIMES WITH NO LUCK. THE PRODUCT SEEMED TO BE DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309316 SPACEMAKER BLUNT TIP TROCAR 10MM SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC P3K0783X

    Patients

    Seq Age Sex Outcome Treatment
    1