BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 2935828 · Received January 2, 2013

    Report

    Report Number
    2647580-2012-00820
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 19, 2012
    Report Date
    December 4, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT AT THE VERY BEGINNING OF THE PROCEDURE, THE 'LID' THROUGH WHICH THE INSTRUMENT IS INSERTED DISCONNECTED FROM THE TROCAR. NO ILL EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617 SPACEMAKER BLUNT TIP TROCAR 10MM SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P2H0199X

    Patients

    Seq Age Sex Outcome Treatment
    1