BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA Q REFLEX

    MDR report key: 7697249 · Received July 17, 2018

    Report

    Report Number
    3013515803-2018-00008
    Event Type
    Injury
    Date Received
    July 17, 2018
    Date of Event
    June 1, 2018
    Report Date
    July 18, 2018
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    PMA / PMN Number
    K992824
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS SOON AS ELLEX MEDICAL BECAME AWARE OF THE INCIDENT, ELLEX INC USA HAS REQUESTED THE USER FACILITY FOR GETTING THE DEVICE VERIFIED , TO CONFIRM THE DEVICE OPERATED TO SPECIFICATIONS AND TO CHECK ON THE PATIENT STATUS . HOWEVER THE USER FACILITY HASN'T RESPONDED TILL DATE. AS CONFIRMED BY ELLEX INC., THE PRODUCT HAS HAD EXCELLENT SERVICE HISTORY FOR YEARS. ELLEX MEDICAL HAS CHECKED THE DHR (COMMISSIONING BOOK) AND HAVE CONFIRMED THAT THE CALIBRATION OF THE LASER SYSTEM , ALIGNMENT OF THE OPTICAL PATHS, OFFSET CHECKS HAD CONFORMED TO SPECIFICATION. THE GENERAL DEVICE ASPECTS WITH RESPECT TO USABILITY, INSTRUCTIONS FOR USE AND THE RISK CONTROLS WERE EVALUATED. ADEQUACY OF DEVICE DESIGN: INDICATIONS OF PARAMETERS RELEVANT TO SAFETY : ANTERIOR AND POSTERIOR OFFSET LOCATED ON THE LASER HEAD CONTROL KNOB ARE LETTER AND COLOUR CODED . ACCURACY OF CONTROLS: OFFSET RANGE IS WELL DEFINED WITH THE REQUIRED TOLERANCE. ADEQUACY OF LABELLING: OPERATOR MANUAL (INCLUDED IN ATTACHMENT) INCLUDES SUFFICIENT INSTRUCTIONS , WARNINGS, PRECAUTIONS FOR THE SAFE USE OF THE DEVICE AND THE LABELLING IS CONSIDERED ADEQUATE. RISK MANAGEMENT : REVIEW INDICATED THAT THE RISK CONTROL MEASURES ( RA TANGO REFLEX-08 IN ATTACHMENT) ARE ADEQUATE AND WITHIN THE NORMAL USE RISK LEVELS ARE ACCEPTABLE. CUSTOMER COMPLAINTS : THE DEVICE HAS BEEN IN USE FOR 5 YEARS FROM THE DATE OF INSTALLATION; NO OTHER UNTOWARD INCIDENTS RELATED TO DEVICE USE WERE REPORTED APART FROM THIS EVENT. E2018008.

    Description of Event or Problem · 0

    PHYSICIAN HIT THE PATIENT'S RETINA VESSEL WHICH RESULTED IN BLOOD MIGRATING INTO THE VITREOUS AND REDUCED VISUAL ACUITY FOR THE PATIENT. THIS LASER TREATMENT WAS TO THE RIGHT EYE ONLY. PATIENT SAYS THAT THE BLOOD IS DISAPPEARING AND THEIR VISON IS BETTER SINCE THE PROCEDURE, BUT STILL SOMEWHAT BLURRY. POSSIBLE USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535136 ULTRA Q REFLEX OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LQP3106-U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other