BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5-2/3MM REDUCER

    MDR report key: 1163399 · Received September 10, 2008

    Report

    Report Number
    2647580-2008-00530
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 22, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K950632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING SURGERY, INSERTION PART FOR SURGICAL INSTRUMENT DISENGAGED. THE OPERATION WAS STOPPED TEMPORARILY TO SEARCH THE MISSING PIECE. IT WAS FOUND INSIDE SEAL OF 5 MM STEP. NOTHING FELL INTO THE CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER. EXTENDED OR TIME: UNK. THERE WAS NO TISSUE DAMAGE AND NO BLEEDING. PT STATUS: OK. NO PT INJURY WAS REPORTED. NO FURTHER PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5-2/3MM REDUCER DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS

    Patients

    Seq Age Sex Outcome Treatment
    1