BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI STEP 7/8MM CANN/DILATOR WITH SLEEVE

    MDR report key: 3896729 · Received May 20, 2014

    Report

    Report Number
    2647580-2014-00369
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K961430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: TOTAL LAPAROSCOPIC HYSTERECTOMY. ACCORDING TO THE REPORTER: PIECE OF TROCAR SEAL TORN AND ENTERED INTO PT. PIECE RECOVERED AND REMOVED WITH DEVICE. RETRIEVED FROM INSIDE PT AND MOVED ON WITH PROCEDURE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES. A DEVICE FRAGMENT FELL INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299666 MINI STEP 7/8MM CANN/DILATOR WITH SLEEVE DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P3E0691X

    Patients

    Seq Age Sex Outcome Treatment
    1