BEUDAMED
    FDA Adverse Event Other Summary report: N

    PKS OMNI WITH ATTACHED CORD

    MDR report key: 2467728 · Received February 15, 2012

    Report

    Report Number
    2183680-2012-00009
    Event Type
    Other
    Date Received
    February 15, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 16, 2012
    Manufacturer
    GYRUS MEDICAL INC.,
    Product Code
    GEI
    PMA / PMN Number
    K081766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF THE DEVICE HAVING A BROKEN TIP IS CONFIRMED. THE DEVICE WAS RETURNED WITH THE HUB BEING FRACTURED. THERE WERE NO MISSING PIECES. THE FRACTURE OCCURRED UNDER THE HEAT SHRINK COVERING OF THE SHAFT. UPON REMOVAL OF THE HEAT SHRINK IT WAS OBSERVED THAT THIS IS A CLEAN BREAK, WHEN THE TWO PIECES ARE PLACED BACK TOGETHER ALL PARTS OF THE HUB ARE ACCOUNTED FOR. THE FRACTURE SITE IS AT THE THIN TO THICK TRANSITION ARE OF THE HUB JUST TO THE PROXIMAL SIDE OF THE CENTER PIVOT RIVET. A REVIEW OF THE MFR BUILD RECORDS AND THE COMPONENT RECORDS DO NOT INDICATE ANY DISCREPANCIES IN THE MFR OF THE DEVICE OR WITH THE HUB COMPONENT. FRACTURES SUCH AS THESE HAVE BEEN ATTRIBUTED TO THE DISTAL END OF THE DEVICE BEING EXPOSED TO EXCESSIVE FORCE OR THE DEVICE BEING USED IN SUCH A MANNER THAT THEY ARE STRESSED BEYOND THE INTENDED SPECIFICATION OF THE DEVICE. WE WILL CONTINUE TO MONITOR THE COMPLAINT DATA BASE FOR FURTHER OCCURENCES.

    Description of Event or Problem · 1

    GYRUSACMI WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE TIP OF THE SUBJECT DEVICE BROKE INSIDE THE PT. THE TIP BROKE BUT REMAINED ATTACHED TO THE FORCEP. THE FORCEP WAS REPLACED WITH ANOTHER OF THE SAME MODEL AND THE SAME OCCURRED A SECOND AND THIRD TIME. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS OMNI WITH ATTACHED CORD PKS OMNI WITH ATTACHED CORD GEI GYRUS MEDICAL INC., 970010PC 371787JD

    Patients

    Seq Age Sex Outcome Treatment
    1