BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIGUIDE FIBER

    MDR report key: 7117438 · Received December 14, 2017

    Report

    Report Number
    3005350457-2017-00001
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    November 10, 2017
    Report Date
    December 13, 2017
    Manufacturer
    OMNIGUIDE, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADVERSE EVENT WAS REPORTED BY A (B)(6) TECHNICIAN ON AN OTO-S FIBER (GEN1 LASER) ON (B)(6) 2017. THE GAS SETTING WAS ACCIDENTLY SET AT 70 PSI INSTEAD OF 10 PSI (AS INDICATED IN THE PROCEDURAL SETTINGS GUIDE). SURGEON STATED THAT THE EXCESSIVE GAS FLOW CAUSED INNER EAR INFLAMMATION. THE PATIENT HAD TO EXTEND THE STAY IN THE HOSPITAL. SURGEON STATED THAT THE HEARING WAS GOOD BUT WAS TREATED WITH STEROIDS FOR DIZZINESS. SURGEON MENTIONED THAT THE CONDITION WILL RESOLVE COMPLETELY WITH TIME. THE PRODUCT WAS NOT SENT BACK FOR EVALUATION, NO FAILURE OF THE FIBER WAS REPORTED. THE LASER WAS INSPECTED AND A PREVENTIVE MAINTENANCE WAS CONDUCTED WHICH DID NOT REVEAL ANY FAILURES WITH THE LASER UNIT.

    Description of Event or Problem · 1

    AN ADVERSE EVENT WAS REPORTED BY A (B)(6) TECHNICIAN ON AN OTO-S FIBER (GEN1 LASER) ON (B)(6) 2017. THE GAS SETTING WAS ACCIDENTLY SET AT 70 PSI INSTEAD OF 10 PSI (AS INDICATED IN THE PROCEDURAL SETTINGS GUIDE). SURGEON STATED THAT THE EXCESSIVE GAS FLOW CAUSED INNER EAR INFLAMMATION. THE PATIENT HAD TO EXTEND THE STAY IN THE HOSPITAL. SURGEON STATED THAT THE HEARING WAS GOOD BUT WAS TREATED WITH STEROIDS FOR DIZZINESS. SURGEON MENTIONED THAT THE CONDITION WILL RESOLVE COMPLETELY WITH TIME. THE PRODUCT WAS NOT SENT BACK FOR EVALUATION, NO FAILURE OF THE FIBER WAS REPORTED. THE LASER WAS INSPECTED AND A PREVENTIVE MAINTENANCE WAS CONDUCTED WHICH DID NOT REVEAL ANY FAILURES WITH THE LASER UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895728 OMNIGUIDE FIBER OTOLOGY FIBER GEX OMNIGUIDE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other