BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO

    MDR report key: 23069792 · Received September 16, 2025

    Report

    Report Number
    3002806902-2025-00002
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 28, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    PMA / PMN Number
    K212630
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    WE UNDERSTOOD THAT IN JUNE 25, ANNUAL SERVICE MAINTENANCE WAS CARRIED OUT AND THE SLT ENERGIES WERE TOO LOW. THE SERVICE TECHNICIAN DID A CALIBRATION AND AFTERWARDS THEY WERE MEASURED TO BE OK. THEN LATER IN AUGUST 25, THE USER FACILITY WAS AUDITED BY AN EXTERNAL ORGANIZATION THAT CHECKS SECURITY OF DEVICES AND FOUND THE REPORTED SLT ISSUE. THE HOSPITAL NOTIFIED OUR REPRESENTATIVE IN FRANCE AND STOPPED USING THE DEVICE. THE DEVICE WAS VERIFIED BY THE COMPANY REPRESENTATIVE AND CONFIRMED THE FAULT OBSERVED BY THE EXTERNAL ORGANISATION. A LOAN UNIT IS ARRANGED UNTIL THE DEVICE IS INVESTIGATED FOR THE CAUSE OF THE ISSUE. HOWEVER NO INJURIES WERE REPORTED AND THE USERS DID NOT COMPLAIN OF HIGH ENERGY DURING THIS PERIOD. THIS IS A FOLLOW UP REPORT, THE UPDATES ARE AS BELOW: THE ROOT CAUSE OF THE EXCESS ENERGY IN SLT MODE WAS DUE TO A MIS-CALIBRATION THAT OCCURRED DURING THE LAST SERVICING /MAINTENANCE ACTIVITY IN JUNE 2025, ATTRIBUTED TO THE POOR POSITIONING OF THE MEASURING INSTRUMENT BY THE SERVICE TECHNICIAN, BECAUSE OF WHICH THE SLT ENERGY OUTPUT MEASURED WAS LOW, RESULTING IN THE MIS-CALIBRATION. -THIS INCIDENT WAS CONFIRMED TO BE AN ISOLATED ONE, THE UNIT HAS BEEN IN USE FOR 10 YEARS WITH NO SUCH INCIDENTS REPORTED, NOR WERE SUCH ISSUES REPORTED FOR ANY OTHER UNITS IN THE FIELD. 5 REPRESENTATIVE UNITS CALIBRATED BY THE TECHNICIAN, WERE VERIFIED AND FOUND TO BE CORRECT. THE CONFORMITY OF THE ENERGY METER WAS ALSO CONFIRMED TO BE ACCURATE. A REFRESHER TRAINING WAS ORGANISED FOR THE TECHNICIAN FOR TESTING OF YAG /SLT SYSTEMS. THE IMPACTED UNIT POST CORRECTION WAS RE-INSTALLED IN THE FACILITY. THE ADVERSE EVENT CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION HAVE BEEN UPDATED IN SECTION H6.

    Additional Manufacturer Narrative · 0

    WE UNDERSTOOD THAT IN JUNE 25, ANNUAL SERVICE MAINTENANCE WAS CARRIED OUT AND THE SLT ENERGIES WERE TOO LOW. THE SERVICE TECHNICIAN DID A CALIBRATION AND AFTERWARDS THEY WERE MEASURED TO BE OK. THEN LATER IN AUGUST 25, THE USER FACILITY WAS AUDITED BY AN EXTERNAL ORGANIZATION THAT CHECKS SECURITY OF DEVICES AND FOUND THE REPORTED SLT ISSUE. THE HOSPITAL NOTIFIED OUR REPRESENTATIVE IN FRANCE AND STOPPED USING THE DEVICE. THE DEVICE WAS VERIFIED BY THE COMPANY REPRESENTATIVE AND CONFIRMED THE FAULT OBSERVED BY THE EXTERNAL ORGANISATION. A LOAN UNIT IS ARRANGED UNTIL THE DEVICE IS INVESTIGATED FOR THE CAUSE OF THE ISSUE. HOWEVER NO INJURIES WERE REPORTED AND THE USERS DID NOT COMPLAIN OF HIGH ENERGY DURING THIS PERIOD.

    Description of Event or Problem · 0

    RECEIVED A COMPLAINT FOR A TANGO UNIT (INSTALLED IN 2015) IN FRANCE, THAT THE ENERGY DELIVERED IN SLT MODE EXCEEDED THE +20% THRESHOLD, NO PATIENTS INVOLVED.

    Description of Event or Problem · 0

    RECEIVED A COMPLAINT FOR A TANGO UNIT (INSTALLED IN 2015) IN FRANCE, THAT THE ENERGY DELIVERED IN SLT MODE EXCEEDED THE +20% THRESHOLD, NO PATIENTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553008 TANGO OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LT5106-T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other