BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA Q REFLEX

    MDR report key: 6140255 · Received December 1, 2016

    Report

    Report Number
    9680659-2016-00003
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    September 23, 2016
    Report Date
    December 2, 2016
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS SOON AS ELLEX MEDICAL BECAME AWARE OF THE INCIDENT , THE DEVICE WAS CONTAINED . THE CALIBRATION OF THE LASER SYSTEM AND ALIGNMENT OF THE OPTICAL PATHS WAS VERIFIED BY ELLEX SERVICE THROUGH A PAF (PRODUCT ACCEPTANCE FAULT RECORD IN SUPPORTING DATA). ALL THE PARAMETERS IN ALIGNMENTS CHECKS INCLUDING OFFSET IN THE PAF ARE WITHIN THE ACCEPTANCE CRITERIA WHICH PROVES THAT THE DEVICE IS NOT AT FAULT AND IS PERFORMING WITHIN THE NORMAL SPECIFICATIONS. THE PREVIOUS RECORD DURING INSTALLATION WAS ALSO FOUND TO BE COMPLIANT. THE GENERAL DEVICE ASPECTS WITH RESPECT TO USABILITY, INSTRUCTIONS FOR USE AND THE RISK CONTROLS WERE ALSO EVALUATED. ADEQUACY OF DEVICE DESIGN : A) INDICATIONS OF PARAMETERS RELEVANT TO SAFETY : OFFSET IS INDICATED ON LASER HEAD CONTROL KNOB BY, A/P NUMBERED & COLOUR CODED INDICATIONS (THE LETTER A AND THE COLOUR ORANGE ON THE OFFSET CONTROL INDICATE ANTERIOR POSITIONS. THE LETTER P AND THE COLOUR BLUE ON THE OFFSET CONTROLS INDICATE POSTERIOR POSITIONS.) ACCURACY OF CONTROLS : ±500 MICRO M OFFSET RANGE WITH TOLERANCE OF ±50 MICRO M (PRODUCT REQUIREMENT SPECIFICATION IN SUPPORTING DATA) OFFSET CHECKS CONFIRMED DURING PRODUCTION (COMMISSIONING BOOK IN SUPPORTING DATA) . PRODUCT ACCEPTANCE FAULT RECORDS DURING INSTALLATION , ANNUAL SERVICE AND POST THE EVENT ALSO CONFIRMED THE OFFSET RESULTS WERE NORMAL. ADEQUACY OF LABELLING : OPERATOR MANUAL (INCLUDED IN SUPPORTING DATA) INCLUDES SUFFICIENT INSTRUCTIONS , WARNINGS , PRECAUTIONS FOR THE SAFE USE OF THE DEVICE AND THE LABELLING IS CONSIDERED ADEQUATE. DO NOT AIM, FOCUS OR FIRE THIS DEVICE IN, ON OR NEAR THE FOVEA; ON CORNEAL STRUCTURES; ON THE PATIENT'S LENS (NATURAL OR ARTIFICIAL); OR ON ANY OTHER STRUCTURE OF THE HUMAN BODY THAT IS NOT RELATED TO THE TREATMENT OF AN EYE DISORDER. ALWAYS CONFIRM THE OFFSET DIRECTION (ANTERIOR (A) OR POSTERIOR (P)) AND OFFSET MEASUREMENT BEFORE YOU FIRE THE TREATMENT LASER. WHEN TREATING CLOSE TO THE POSTERIOR LENS SURFACE A POSTERIOR OFFSET SHOULD BE CONSIDERED. SET THE POSTERIOR (P) OFFSET TO AT LEAST 100MICROM WITH A MINIMUM ENERGY SETTING. IF USING A HIGHER ENERGY SETTING CHOOSE A GREATER POSTERIOR (P) OFFSET. ONLY FULLY TRAINED AND QUALIFIED PHYSICIANS MAY OPERATE THIS DEVICE. THIS DEVICE IS A SAFE INSTRUMENT WHEN USED CORRECTLY. HOWEVER, LIKE ALL LASER SURGICAL EQUIPMENT, IT CAN CAUSE INJURY IF NOT USED IN ACCORDANCE WITH THE CORRECT SAFETY PROCEDURES AND OPERATING INSTRUCTIONS. RISK MANAGEMENT : REVIEW INDICATED THAT THE RISK CONTROL MEASURES ( RISK ASSESSMENT IN SUPPORTING DATA) ARE ADEQUATE AND WITHIN THE NORMAL USE RISK LEVELS ARE ACCEPTABLE. CUSTOMER COMPLAINTS : THE DEVICE HAS BEEN IN USE FOR 1 YEARS , NO OTHER UNTOWARD INCIDENTS RELATED TO DEVICE USE WERE REPORTED . THE DELAY IN REPORTING IS DUE TO THE FACT THAT SUFFICIENT DETAILS OF THE INCIDENT HAVE NOT BEEN MADE AVAILABLE FROM THE USER FACILITY.

    Description of Event or Problem · 1

    THE INCIDENT OCCURED IN (B)(6) USA ; THE LASER HIT THE POSTERIOR SURFACE OF THE PATIENT'S NATURAL LENS AND ALSO THE RETINA, BOTH ON THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789236 ULTRA Q REFLEX OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LQP3106-U

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability