BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSCAN

    MDR report key: 14460237 · Received May 20, 2022

    Report

    Report Number
    3002806902-2022-00002
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    April 6, 2022
    Report Date
    May 20, 2022
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    UDI-DI
    09342395000168
    PMA / PMN Number
    K142398
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DOCTOR TREATED THE BLEEDING WITH LASER PHOTOCOAGULATION. THE BLEEDING RESOLVED WITHOUT ANY COMPLICATIONS AFTER THE PHOTOCOAGULATION. THERE WAS NO DEVICE PROBLEM, THE DEVICE WAS VERIFIED AFTER THE EVENT, AND IT WAS WITHIN SPECIFICATIONS. THE DEVICE LABELLING AND RISK CONTROL MEASURES WERE REVIEWED AND CONSIDERED ADEQUATE. ACCORDING TO THE CLINICAL EXPERT, SOMETIMES THE LASER BREAKS AN INTER RETINAL VESSEL AND BLEEDING OCCURS. THE ENERGY DISCHARGE NEAR THE VESSELS SOMETIMES MAY BE A LITTLE HIGH WHICH CAN CAUSE BLEEDING.

    Description of Event or Problem · 0

    THERE WAS AN INCIDENT REPORTED ON THE ELLEX PROSCAN LASER USED IN A (B)(6) EYE CLINIC. DURING PHOTOCOAGULATION FOR A RETINAL TEAR ON A PATIENT, BLEEDING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369000 PROSCAN OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LP6Y 09342395000168

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention