BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS OMNI

    MDR report key: 2996865 · Received March 6, 2013

    Report

    Report Number
    2183680-2013-00017
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 4, 2013
    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 HAS BEEN DISCARDED BY THE FACILITY. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS (B)(4) WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GYRUS (B)(4) THAT MULTIPLE ATTEMPTS TO CUT PEDICLES DURING A LAP HYSTERECTOMY, THE DEVICE WAS NOT ACTUALLY CUTTING BUT WAS CREATING CHAR. THERE WAS NO PATIENT INJURY REPORTED, THE PROCEDURE WAS PROLONGED BY 30 MINUTES, AND CONVERTED USING THE LIGASURE TO COMPLETE. (SEE MFR REPORT # 2183680-2013-00016 FOR FIRST DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94634 PKS OMNI PKS OMNI GEI GYRUS MEDICAL, INC. 970010PC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK