BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA Q REFLEX

    MDR report key: 8058542 · Received November 11, 2018

    Report

    Report Number
    3013515803-2018-00011
    Event Type
    Injury
    Date Received
    November 11, 2018
    Date of Event
    October 11, 2018
    Report Date
    November 12, 2018
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    UDI-DI
    09342395000038
    PMA / PMN Number
    K992824
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 ) ATTACHED. ALL THE PARAMETERS IN ALIGNMENTS CHECK 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 GENERAL DEVICE ASPECTS WITH RESPECT TO USABILITY, INSTRUCTIONS FOR USE AND THE RISK CONTROLS WERE EVALUATED . 1) ADEQUACY OF DEVICE DESIGN : A) INDICATIONS OF PARAMETERS RELEVANT TO SAFETY : ANTERIOR AND POSTERIOR OFFSET LOCATED ON THE LASER HEAD CONTROL KNOB ARE LETTER AND COLOUR CODED . B) ACCURACY OF CONTROLS : OFFSET RANGE IS WELL DEFINED WITH THE REQUIRED TOLERANCE. 2)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. 3) 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. 4) CUSTOMER COMPLAINTS : THE DEVICE HAS BEEN IN USE FOR 7 MONTHS WITH NO UNTOWARD COMPLAINTS. PATIENT MONITORING : PHOTOCOAGULATED THE LESION AS A PROPHYLACTIC MEASURE SINCE THE PHYSICIAN COULD NOT SEE IF THERE WAS A HOLE IN THE RETINA DUE TO THE HEMORRHAGE. PATIENT IS DOING FINE AFTER PHOTOCOAGULATION. THE USER WAS RECOMMENDED TO COMPLETE LASER TRAINING AND THE TRAINING CERTIFICATE HAS BEEN INCLUDED. - ATTACHMENT: [ELLEX_CERTIFICATE_DR. OISHI.ZIP].

    Description of Event or Problem · 0

    THIS IS A FOLLOW UP REPORT. THE EVENT OCCURED IN JAPAN, DOCTOR WAS TREATING A FLOATER ON A PATIENT . ENERGY: STARTED FROM 4MJ, AND INCREASED THE ENERGY GRADUALLY SINCE NOTHING WAS HAPPENING TO THE FLOATER. RETINAL BLEEDING HAPPENED AT 8MJ .THIS REPORT IS MADE BY ELLEX WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

    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 CHECK 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 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 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 7 MONTHS WITH NO UNTOWARD COMPLAINTS. PATIENT MONITORING: PHOTOCOAGULATED THE LESION AS A PROPHYLACTIC MEASURE SINCE THE PHYSICIAN COULD NOT SEE IF THERE WAS A HOLE IN THE RETINA DUE TO THE HEMORRHAGE. PATIENT IS DOING FINE AFTER PHOTOCOAGULATION. (B)(4).

    Description of Event or Problem · 1

    THE EVENT OCCURED IN (B)(6), DOCTOR WAS TREATING A FLOATER ON A PATIENT . ENERGY: STARTED FROM 4MJ, AND INCREASED THE ENERGY GRADUALLY SINCE NOTHING WAS HAPPENING TO THE FLOATER. RETINAL BLEEDING HAPPENED AT 8MJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898107 ULTRA Q REFLEX OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LQP3106-U 09342395000038

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention