BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 3190610 · Received June 13, 2013

    Report

    Report Number
    2647580-2013-00324
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 21, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP VENTRAL HERNIA REPAIR. ACCORDING TO THE REPORTER: WHEN INSERTING MESH INTO THE TROCAR, THE RUBBER SEAL COLLAPSED PARTLY INTO THE TROCAR. A NEW BLUNT TIP BALLOON TROCAR WAS USED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270506 SPACEMAKER BLUNT TIP TROCAR 10MM DISPOSABLE SURGICAL ACESS DEVICE GCJ COVIDIEN, FORMERLY USSC PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1