BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS OMNI WITH ATTACHED CORD

    MDR report key: 2630966 · Received June 21, 2012

    Report

    Report Number
    2183680-2012-00036
    Event Type
    Injury
    Date Received
    June 21, 2012
    Date of Event
    March 6, 2012
    Report Date
    May 24, 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 DEVICE WAS EVALUATED AND FOUND THAT THE JAW IS NOT BROKE AS REPORTED BY THE CALLER. THE CUT SPRING IS RAISED UP ABOVE THE BACK SIDE OF THE JAW. IT MAY APPEAR TO BE BROKEN TO THE END USER. THERE IS EVIDENCE OF THE DEVICE BEING USED, COAGULATE ON TOP OF THE CUT SPRING. THE END OF THE CUT SPRING MAY HAVE BEEN RAISED OR PULLED FROM THE JAW BY THE USER DURING THE RECOMMENDED CLEANING OF THE JAWS DURING USE. ALL PARTS ARE ACCOUNTED FOR. REFER TO THE IFU FOR THE PROPER CLEANING METHODS. THIS APPEARS TO BE AN ISOLATED INCIDENT, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GYRUS ACMI THAT DURING A SURGICAL PROCEDURE, THE TIP OF THE OMNI BROKE PROXIMAL TO THE JAW DURING SURGERY. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS OMNI WITH ATTACHED CORD PKS OMNI GEI GYRUS MEDICAL INC. 970010PC 384304KD

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK