BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAQ

    MDR report key: 18892087 · Received March 13, 2024

    Report

    Report Number
    3002806902-2024-00001
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    February 26, 2024
    Report Date
    March 13, 2024
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    PMA / PMN Number
    K212630
    Removal / Correction Number
    COR21000397
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS SOON AS ELLEX BECAME AWARE OF THE EVENT , THE DEVICE WAS QUARANTINED AND BASED ON THE DEVICE DETAILS , THE UNIT WAS TRACED TO THE 2007 RECALL , WHICH WAS REITERATED IN 2020. THE CORRECTION WAS NOT CARRIED OUT FOR THIS UNIT , WHICH HAS RESULTED IN THE UNINTENDED LASER FIRING. THE EVENT WAS REPORTED TO FDA UNDER 21CFR1003 IN 2020 AND CORRECTIVE ACTION PLAN WAS DONE IN ACCORDANCE WITH 21 CFR 1004.. THIS UNIT HAS BEEN DECOMMISSIONED FOR FURTHER USE.

    Description of Event or Problem · 0

    AN UNINTENDED LASER FIRING HAS BEEN REPORTED IN GERMANY FOR A PENDING 2007RECALL UNIT OF ULTRAQ. THERE WAS NO PATIENT INVOLVED , NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135063 ULTRAQ OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LQP3106-U

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other