BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGO REFLEX

    MDR report key: 10518779 · Received September 10, 2020

    Report

    Report Number
    3002806902-2020-00005
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    August 7, 2020
    Report Date
    September 10, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVENT, THE DOCTOR DEPRESSED THE LASER LENS ON THE PATIENT EYE FOR ONE HOUR UNTIL THE CLOTTING MECHANISM SEALED THE INJURY. THERE WAS SOME BLOOD IN THE VITREOUS AND THE DOCTOR IS HOPEFUL IT WILL BE REABSORBED AND CLEAR UP. THE STATUS OF PATIENT FOLLOW UP WITH THE RETINA SPECIALIST IS AWAITED. AS SOON AS ELLEX WAS NOTIFIED OF THE EVENT ,THE DEVICE WAS VERIFIED AND WAS FOUND TO BE WITHIN SPECIFICATIONS. THE DEVICE LABELLING AND RISK CONTROL MEASURES WERE DETERMINED TO BE ADEQUATE.

    Description of Event or Problem · 1

    DOCTOR WAS PERFORMING POSTERIOR MEMBRANECTOMY WITH A TANGO-REFLEX LASER IN YAG MODE AND HE HIT A VESSEL TIED IN WITH THE OPTIC NERVE AND A HAEMORRHAGE OCCURRED. THE DOCTOR REFERRED PATIENT TO A RETINA SPECIALIST FOR FURTHER EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982567 TANGO REFLEX OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LT5106-T 09342395000298

    Patients

    Seq Age Sex Outcome Treatment
    1 Other