BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO REFLEX

    MDR report key: 6524924 · Received April 26, 2017

    Report

    Report Number
    9680659-2017-00001
    Event Type
    Malfunction
    Date Received
    April 26, 2017
    Date of Event
    April 4, 2017
    Report Date
    April 27, 2017
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    GEX
    PMA / PMN Number
    K021550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS SOON AS THE EVENT WAS IDENTIFIED, A STOP SHIPMENT' WAS ORDERED ON 5TH APRIL 2017 FOR FINISHED GOODS RELEASE FROM SERVICE SUBSIDIARIES TO CUSTOMERS, INCLUDING DEMO UNTIL FURTHER NOTICE. NO SERVICE ACTIVITIES WERE ALLOWED TO OCCUR ON EXISTING UNITS AND THE EXISTING STOCKS WERE QUARANTINED / SEGREGATED IN THE WAREHOUSE WITH EITHER A RED TAG OR IDENTIFICATION. INVESTIGATION AND ROOT CAUSE ANALYSIS DETERMINED A FAULT WITH CABLE MANAGEMENT WITHIN THE DELIVERY HEAD CABLE ASSEMBLY. ALL CUSTOMERS OF THE AFFECTED UNITS WERE ADVISED ON 10TH APRIL 2017, OF THE CONTAINMENT ACTION THROUGH A CUSTOMER COMMUNICATION: SAFETY UPDATE (CABLE MANAGEMENT)' AND ADVISED AGAINST USING THE SYSTEM UNTIL INSPECTED AND SERVICED BY ELLEX TECHNICAL TEAM. DESIGN CORRECTION WITH INCLUSION OF SPACER /COLLAR CAPABLE OF BEING INSTALLED IN THE FIELD, CARRIED OUT TO PREVENT THE SLIT LAMP FROM BEING LOWERED TO THE POINT WHERE THE CABLE CAN BE CRUSHED. CABLE MANAGEMENT IMPROVED TO RELIABLY CONTROL THE MOVEMENT OF THE CABLES. SERVICE ACTION FOR INSPECTING, REPLACING AND MANAGING THE DELIVERY HEAD CABLE ASSEMBLY TO BE UNDERTAKEN AS INSTRUCTED IN GLOBAL CUSTOMER SERVICE SAFETY BULLETIN SB-17-09 TANGO REFLEX¿ CABLE MANAGEMENT MANDATORY INSPECTION / REWORK AND GLOBAL CUSTOMER SERVICE TECHNICAL BULLETIN TB-17-07A (10) TANGO REFLEX LASER HEAD CABLE ASSEMBLY REPLACEMENT ISSUED ON 12TH APRIL 2017. GLOBAL CUSTOMER SERVICE SAFETY BULLETIN SB-17-11 TANGO REFLEX¿ CABLE MANAGEMENT -SUMMARY ISSUED TO DISTRIBUTORS ON 27TH APRIL 2017. WE ARE TARGETING TO COMPLETE ALL THE CORRECTIVE ACTIONS BY 31ST MAY 2017. SHIPMENT RESTARTED ON 12TH APRIL, VIA 'RESTART SHIPMENT' NOTIFICATION WITH INCLUSION OF THE NEW COLLAR AND CABLE MANAGEMENT IN THE PRODUCTION UNITS. TANGO REFLEX SYSTEMS SERIAL (B)(4) ONWARDS HAVE BEEN PRODUCED AS PER THE NEW DESIGN.

    Description of Event or Problem · 1

    THE DEFECT WAS OBSERVED IN USA ON TANGO REFLEX (B)(4) ON (B)(6) 2017 AS SOON AS THE UNIT WAS INSTALLED; HOWEVER, BEFORE USE ON THE PATIENTS, THE DOCTOR REPORTED HE WAS UNABLE TO GET THE SYSTEM INTO READY MODE AND CALLED IN SUPPORT FROM AN ELLEX SERVICE ENGINEER. DURING INVESTIGATION, THE ENGINEER NOTICED THAT THE UNIT PRODUCED A LASER EMISSION WITHOUT PRESSING THE FIRE BUTTON WHEN THE SLITLAMP WAS DRIVEN TO ITS LOWEST POSITION PRIOR TO USE ON ANY PATIENT. THE DEVICE WAS TAKEN BACK TO THE ELLEX USA OFFICE. THIS FAULT WAS ABLE TO BE REPLICATED ON A UNIT ((B)(4)) AT THE ADELAIDE SERVICE OFFICE WHICH WAS DISASSEMBLED TO LOCATE THE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302904 TANGO REFLEX OPHTHALMIC LASER GEX ELLEX MEDICAL PTY LTD LT5106-T

    Patients

    Seq Age Sex Outcome Treatment
    1