BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO RETRACT II 10MM INSTRUMENT

    MDR report key: 2933397 · Received December 21, 2012

    Report

    Report Number
    2647580-2012-00789
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 26, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K920068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPY. ACCORDING TO THE REPORTER: ONCE THE SURGEON TRIED TO OPEN THE RETRACTOR INSIDE THE ABDOMINAL, AN UNIDENTIFIED BLACK PLASTIC PIECE FELL OFF FROM THE RETRACTOR. THE CASE WAS EXTENDED BY NEARLY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO RETRACT II 10MM INSTRUMENT SINGLE USE LAPAROSCOPIC HAND INSTRUMENT GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P2F0188X

    Patients

    Seq Age Sex Outcome Treatment
    1