BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO RETRACT II 10MM INSTRUMENT

    MDR report key: 2823507 · Received October 8, 2012

    Report

    Report Number
    2647580-2012-00634
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 13, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K920068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: WHILE USING THE ENDO RETRACT, A PIECE OF BLACK PLASTIC BROKE AWAY FROM THE INSTRUMENT WHERE THE FAN ARTICULATES. A PIECE FELL INTO THE PT AND WAS RETRIEVED USING A GRASPER. THEY THEN USED A SECOND DEVICE AND THE SAME HAPPENED TWO INSTRUMENTS ARE BEING RETURNED WITH THE SAME LOT NUMBER. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO RETRACT II 10MM INSTRUMENT SINGLE USE SPECIMEN RETRIEVAL PRODUCT GCJ COVIDIEN, FORMERLY USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1