BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGO REFLEX

    MDR report key: 10760545 · Received October 30, 2020

    Report

    Report Number
    3002806902-2020-00006
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    September 2, 2020
    Report Date
    October 30, 2020
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    UDI-DI
    09342395000298
    PMA / PMN Number
    K021550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PERFORMANCE WAS VERIFIED THROUGH A PRODUCT ACCEPTANCE FAULT RECORD , THE DEVICE PERFORMED WITHIN SPECIFICATIONS , THE OCULARS WERE DIRTY , HOWEVER WAS NOT THE CAUSE OF THE EVENT. THE PROBABLE CAUSE OF THE INCIDENT WAS USER ERROR.

    Description of Event or Problem · 1

    THERE WAS AN INCIDENT USING TANGO REFLEX ON ONE OF THE PATIENTS FOR ELECTIVE LASER TREATMENT OF VITREOUS OPACITIES WHERE IN, THERE WAS AN IMPACT TO THE PATIENT RETINA (MACULAR SCAR) DURING THE THIRD LASERING SESSION, THE 1ST TWO BEING UNEVENTFUL. THERE WAS NO DEVICE FAULT EXCEPT THE OCULARS WERE DIRTY. PATIENT VISUAL ACUITY DROPPED FROM 1.0 TO 0.4 , AND THERE WAS MACULAR PHOTORECEPTOR DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230024 TANGO REFLEX OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LT5106-T 09342395000298

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability