BEUDAMED
    FDA Adverse Event Other Summary report: N

    PKS OMNI

    MDR report key: 2484820 · Received March 6, 2012

    Report

    Report Number
    2183680-2012-00019
    Event Type
    Other
    Date Received
    March 6, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 7, 2012
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K982717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE OMNI INDICATES THAT THE TIP IS STILL ATTACHED TO THE DEVICE. THE HUB WAS FOUND TO BE FRACTURED WHICH WOULD CAUSE THE JAWS NOT TO OPEN OR CLOSE PROPERLY. THE FRACTURE SITE IS UNDER THE HEAT SHRINK WHICH COVERS THE SHAFT OF THE DEVICE. THE DEVICE WAS RETURNED VERY DIRTY, HEAVY DEPOSITS OF COAGULUM COVERED THE DISTAL END OF THE JAW. UPON REMOVAL OF THE HEAT SHRINK AROUND THE FRACTURE SITE, COAGULUM AND OTHER MATERIAL FELL OFF THE DEVICE. WHEN THE DEVICE WAS CLEANED AND THE TWO HALVES OF THE HUB WERE PLACED BACK TOGETHER, COULD NOT CONFIRM THAT ALL THE PARTS WERE ACCOUNTED FOR. A SMALL CHIP WAS MISSING FROM THE EDGE OF THE HUB. FRACTURES SUCH AS THESE HAVE BEEN ATTRIBUTED TO THE DEVICE BEING EXPOSED TO FORCES BEYOND ITS DESIGN INTENT. WE WILL CONTINUE TO MONITOR THE DATA BASE FOR FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE THE OMNI BROKE INSIDE THE PATIENT, NO PIECES FELL OFF THE DEVICE, THE PIECE THAT BROKE IS STILL ATTACHED TO THE DEVICE. A NEW DEVICE WAS OPENED TO FINISH THE CASE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS OMNI PKS OMNI GEI GYRUS MEDICAL INC. 970010PC 330788ED

    Patients

    Seq Age Sex Outcome Treatment
    1