BEUDAMED
    FDA Adverse Event Other Summary report: N

    PKS OMNI

    MDR report key: 2470698 · Received February 24, 2012

    Report

    Report Number
    2183680-2012-00020
    Event Type
    Other
    Date Received
    February 24, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 20, 2012
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K081766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITH HEAVY COAG ON THE JAWS. VISUAL INSPECTION REVEALED THAT THE HUB WAS FRACTURED AND ONE SMALL PIECE WAS MISSING. THE MISSING PIECE WAS NOT RETURNED WITH THE DEVICE. FAILURES OF THIS NATURE CAN BE ATTRIBUTED TO EXCESSIVE FORCE APPLIED TO THE DISTAL END OF THE DEVICE.

    Description of Event or Problem · 1

    GYRUS ACMI WAS INFORMED THAT DURING A SURGICAL PROCEDURE, WHILE MOVING TISSUE LATERALLY THE OMNI WOULD NOT FUNCTION. NO PT HARM, OPENED A NEW OMNI TO FINISH THE CASE WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS OMNI PKS OMNI GEI GYRUS MEDICAL INC. 970010PC 333244ED

    Patients

    Seq Age Sex Outcome Treatment
    1