BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI PKS

    MDR report key: 2482576 · Received February 20, 2012

    Report

    Report Number
    2183680-2012-00010
    Event Type
    Malfunction
    Date Received
    February 20, 2012
    Date of Event
    January 23, 2012
    Report Date
    January 30, 2012
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K081766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CURRENTLY STILL UNDER INVESTIGATION AND TESTING AT OUR FACILITY. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. WHEN FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE RIGHT OUT OF THE BOX, THE JAWS OF THE OMNI WOULD NOT OPEN. THE JAWS WERE PUT IN THE PT AND THEY DID NOT OPEN. USED ANOTHER LIKE DEVICE. NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI PKS OMNI PKS GEI GYRUS MEDICAL, INC. 970010PC

    Patients

    Seq Age Sex Outcome Treatment
    1