BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA Q REFLEX

    MDR report key: 7078243 · Received December 3, 2017

    Report

    Report Number
    9680659-2017-00006
    Event Type
    Injury
    Date Received
    December 3, 2017
    Report Date
    December 4, 2017
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    PMA / PMN Number
    K992824
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS SOON AS ELLEX MEDICAL BECAME AWARE OF THE INCIDENT, THE CALIBRATION OF THE LASER SYSTEM AND ALIGNMENT OF THE OPTICAL PATHS WAS VERIFIED BY ELLEX SERVICE THROUGH A PAF (PRODUCT ACCEPTANCE FAULT RECORD ). 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 AND THERE WAS NO ISSUE WITH ALIGNMENT, MECHANICAL OPERATION OR CALIBRATION. THE GENERAL DEVICE ASPECTS WITH RESPECT TO USABILITY, INSTRUCTIONS FOR USE AND THE RISK CONTROLS WERE ALSO 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. PAF POST THE EVENT ALSO CONFIRMED THE OFFSET RESULTS WERE NORMAL. 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 ( RISK ASSESSMENT RA TANGO-14 IN ATTACHMENT) ARE ADEQUATE AND WITHIN THE NORMAL USE RISK LEVELS ARE ACCEPTABLE. CUSTOMER COMPLAINTS : THE DEVICE HAS BEEN IN USE FOR ALMOST 2 YEARS, NO OTHER UNTOWARD INCIDENTS RELATED TO DEVICE USE WERE REPORTED.

    Description of Event or Problem · 1

    THE ALLEGED EVENT OCCURED IN (B)(6), A YEAR AGO. DURING TREATMENT FOR VITREOUS OPACITY, THE DOCTOR HIT THE NATURAL LENS OF PATIENT, POSSIBLE USER ERROR; HOWEVER THE ACTUAL EVENT NEEDS TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857124 ULTRA Q REFLEX OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LQP3106-U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other