BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI PKS, 5 PACK, 33CM

    MDR report key: 3834518 · Received March 18, 2014

    Report

    Report Number
    2951238-2014-00120
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 24, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVAL. IF ADDITIONAL INFO OR IF THE DEVICE IS RECEIVED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC LAPAROSCOPIC HYSTERECTOMY, THE ELECTRODE DETACHED FROM THE GRASPER. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN MORE DETAILED INFO REGARDING THE REPORT, BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159673 OMNI PKS, 5 PACK, 33CM HANDPIECE GEI GYRUS ACMI INC. 970010PC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1