BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRE PRO /INTEGRE PRO SCAN

    MDR report key: 16560595 · Received March 16, 2023

    Report

    Report Number
    3002806902-2023-00001
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Date of Event
    February 1, 2023
    Report Date
    March 15, 2023
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    PMA / PMN Number
    K081565
    Removal / Correction Number
    TBD UNDER 21CFR1004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTEGRE SPARE (OPTICS BENCH) WAS RETURNED TO ELLEX FOR FAILURE OF LOW OUTPUT POWER FROM THE LASER INDIRECT OPHTHALMOSCOPE (LIO) PORT AND A REPORT OF UNEXPECTED LASER OUTPUT POWER FROM THE SLIT LAMP DELIVERY SYSTEM (SDS) PORT WHEN USING AN LIO. UNDER NORMAL CONDITIONS, WHEN LASER OUTPUT IS DELIVERED THROUGH THE LIO PORT, THE LIO PORT IS SELECTED AND THERE IS NO POWER EMITTED FROM THE SDS. HOWEVER, IN THE REPORTED CASE WHEN THE LASER OUTPUT WAS DELIVERED THROUGH THE LIO PORT, THE POWER WAS LOW AND THERE WAS VISIBLE LASER OUTPUT THROUGH THE SDS. THE INVESTIGATION ESTABLISHED THE CAUSE AS IN INCORRECTLY ASSEMBLED MODULE DUE TO NON-ADHERENCE TO THE MANUFACTURING PROCESS. ALTHOUGH THE ISSUE WAS INITIALLY REPORTED FROM THE FIELD ON 1ST FEB'23 , IT WAS ONLY ON 16TH FEBRUARY THAT THE INVESTIGATION CONFIRMED THE CASE. THIS ISSUE CAN ONLY OCCUR WHEN THE DEVICE IS USED WIHT THE LASER INDIRECT OPHTHALMOSCOPE (LIO). ELLEX HAS ALREADY NOTIFIED THE ELLEX SUBSIDIARIES AND DISTRIBUTORS THROUGH A SAFETY BULLETIN. ELLEX WILL BE REPORTING THE DEFECT AND ITS CORRECTION UNDER 21CFR 1003 , 1004.

    Description of Event or Problem · 0

    ELLEX WAS RECENTLY MADE AWARE OF A POTENTIAL SAFETY ISSUE IMPACTING A SMALL NUMBER OF INTEGRE PRO/INTEGRE PRO SCAN LASERS. THIS WAS REPORTED AS A SINGLE EVENT DURING SERVICING IN AN AUSTRALIAN USER FACILITY, WITH NO INJURY OCCURRING. WHEN USING A LASER-INDIRECT-OPHTHALMOSCOPE (LIO) AS THE DELIVERY DEVICE, A SCATTERED LASER BEAM INSIDE THE LASER CAVITY SYSTEM MAY UNINTENTIONALLY EXIT THROUGH THE SLIT LAMP OUTPUT PORT (SDS) AND GET EMITTED FROM THE OBJECTIVE LENS WHEN THE LASER IS FIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998791 INTEGRE PRO /INTEGRE PRO SCAN OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD 6942942

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other