BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGO REFLEX

    MDR report key: 7008494 · Received November 7, 2017

    Report

    Report Number
    9680659-2017-00005
    Event Type
    Injury
    Date Received
    November 7, 2017
    Date of Event
    August 30, 2017
    Report Date
    November 30, 2017
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    PMA / PMN Number
    K021550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAS BEEN STARTED ON PREGNAZONE AND ZELAZOLAMIDE TO CONTROL IOP AND EDEMA.

    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. THE POSTERIOR OFFSET WAS ADJUSTED AT 300MICROM FROM 400 MICROM, HOWEVER THIS SETTING COULD NOT HAVE CAUSED THE EVENT. 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 ( RISK ASSESSMENT RA TANGO-14) ARE ADEQUATE AND WITHIN THE NORMAL USE RISK LEVELS ARE ACCEPTABLE. CUSTOMER COMPLAINTS : THE DEVICE HAS BEEN IN USE FOR LESS THAN A YEAR, NO OTHER UNTOWARD INCIDENTS RELATED TO DEVICE USE WERE REPORTED.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT . THE PATIENT VISITED THE HOSPITAL FIRST ON 30TH AUGUST FOR THE LASER TREATMENT FOR VITREOUS OPACITY. THE PATIENT EXPERIENCED REDUCED VISION FROM 20/30 TO 20/40, POSTERIOR VITREOUS DETACHMENT, IOP OF 28MM HG AND EPI RETINAL MEMBRANE . AS PER AN UPDATE FROM OUR US OFFICE ON 29TH NOVEMBER , THE PATIENT VISION IS 20/30 IN BOTH EYES AND THE IOP IN THE RIGHT EYE IS 38MM OF HG AND IS BEING TREATED WITH GLAUCOMA MEDICATIONS AS PER THE LAST FOLLOW UP VISIT ON 24TH OCTOBER.

    Description of Event or Problem · 1

    THE EVENT OCCURED IN USA, (B)(6), THE PHYSICIAN POTENTIALLY HIT A PATIENT'S EYE WHICH PROBABLY AFFECTED THE VISUAL ACUITY IN THE RIGHT EYE. HOWEVER THE ACTUAL EVENT AND THE PATIENT OUTCOME NEED TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784953 TANGO REFLEX OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LT5106T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other