BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGO

    MDR report key: 6111746 · Received November 17, 2016

    Report

    Report Number
    9680659-2016-00001
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    July 21, 2016
    Report Date
    October 17, 2016
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    PMA / PMN Number
    K021550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS SOON AS ELLEX MEDICAL BECAME AWARE OF THE INCIDENT, A CAR (ATTACHMENT 7 -CORRECTIVE ACTION REQUEST) WAS RAISED. POSSIBLE CAUSES WERE INVESTIGATED. ADEQUACY OF DEVICE DESIGN : TANGO CAN OPERATE IN BOTH THE YAG/SLT MODE . AFTER EACH SHOT, THE LASER REVERTS TO STANDBY, SO THAT THE TREATMENT MODE HAS TO BE SELECTED EACH TIME BEFORE FIRING THE NEXT SHOT. ADEQUACY OF LABELLING : THE OPERATOR MANUAL (ATTACHMENT 6) MENTIONS 'YAG MODE' FOR INDICATION OF POSTERIOR CAPSULOTOMY, WARNING! (TANGO) ALWAYS CHECK THAT YOU HAVE SELECTED THE CORRECT TREATMENT MODE. EYE DAMAGE MAY RESULT IF THE WRONG MODE IS SELECTED. ONLY FULLY TRAINED AND QUALIFIED PHYSICIANS MAY OPERATE THIS DEVICE.THIS DEVICE IS A SAFE INSTRUMENT WHEN USED CORRECTLY. HOWEVER, LIKE ALL LASER SURGICAL EQUIPMENT, IT CAN CAUSE INJURY IF NOT USED IN ACCORDANCE WITH THE CORRECT SAFETY PROCEDURES AND OPERATING INSTRUCTIONS. RISK MANAGEMENT : REVIEW OF THE RISK ASSESSMENT (ATTACHMENT 5) INDICATED THAT THE RISK CONTROL MEASURES ARE ADEQUATE . THE BELOW RISK CONTROL MEASURES (REFER 1.1.A.5/6/7, 1.1.D.6 ,1.1.H.6, 1.1.I, 1.1 ARE INCLUDED IN THE RISK ASSESSMENT. AFTER START UP, SYSTEM TO ENTER STANDBY AND USER SHOULD SELECT THE TREATMENT LASER MODE (YAG OR SLT), ONLY THE AVAILABLE/SELECTED MODE TO BE DISPLAYED ON RCU. RCU TO SHOW SELECTED MODE AND OPERATOR MUST CONFIRM THE SELECTED WAVELENGTH BEFORE THE SYSTEM WILL ENTER READY STATUS. WHILE THE CENTRE POSITION OF THE ILLUMINATION TOWER IS RECOMMENDED FOR SLT TREATMENTS, IT SHOULD BE 15° OFF CENTRE IN ORDER TO DEACTIVATE THE INTERLOCK AND ALLOW THE SYSTEM TO FIRE IN YAG MODE. DIFFERENT AIMING BEAMS AND FOCUSING METHODS ARE USED BY THE TWO PROCEDURES AND WILL IMMEDIATELY INDICATE TO THE OPERATOR THE TREATMENT MODE SELECTED SYSTEM TO REVERT TO STANDBY UPON CHANGE IN MODE. SYSTEM TO REVERT TO STANDBY IF NO USER ACTIVITY FOR 5 MINUTES AND RETURN TO THE INITIAL SELECT MODE SCREEN INDEPENDENT MECHANICAL SAFETY SHUTTER CLOSED BY SPRING RETURN UNLESS SYSTEM IS IN READY STATUS AND THE FIRE SWITCH IS DEPRESSED. POSITION OF SAFETY SHUTTER IS CONTINUOUSLY MONITORED BY HARDWARE AND SOFTWARE CUSTOMER COMPLAINTS : THE DEVICE HAS BEEN IN USE FOR 5 YEARS AND 11 MONTHS , NO OTHER UNTOWARD INCIDENTS RELATED TO DEVICE USE WERE REPORTED . THE DEVICE SAFETY AND FUNCTIONALITY WAS CONFIRMED THROUGH PRODUCT ACCEPTANCE AND FAULT TEST PROCEDURE ( ATTACHMENT 3 - PRODUCT ACCEPTANCE AND FAULT RECORD) THE DEVICE WAS USED SUBSEQUENT TO THE INCIDENT FROM (B)(6) (WHEN THE PATIENT REPORTED PROBLEM AND THE DEVICE WAS QUARANTINED) WITH NO ADVERSE EVENTS REPORTED. ROOT CAUSE ANALYSIS : A COMPLETE INVESTIGATION (ATTACHMENT 4) CARRIED OUT BY ELLEX INC (B)(4) TO FIND OUT THE ROOT CAUSE REVEALED THAT THE DEVICE FUNCTIONING WAS NORMAL AND THE INCIDENT OCCURED DUE TO THE INCORRECT MODE (SLT) SELECTION BY THE USER. THE FINAL REPORT AND FINDINGS WERE SUBMITTED TO (B)(6) AND HAS BEEN ACKNOWLEDGED. ELLEX ACTION : TECHNICAL SERVICE PERSON TO EXPLAIN TO THE USER OF THE APPROPRIATE MODE SELECTION AND SUGGEST TO THE USER TO READ THE OPERATOR MANUAL BEFORE USE.

    Description of Event or Problem · 1

    LASER TREATMENT USING TANGO SERIAL NUMBER (B)(4) TOOK PLACE ON (B)(6) 2016 AT (B)(6). THE TREATMENT WAS FOR POSTERIOR CAPSULOTOMY DUE TO PCO (POSTERIOR CAPSULE OPACIFICATION) FOLLOWING IOL OPERATION. THE ENERGY SETTING USED WAS 1.3 MJ. THE PATIENT RETURNED FOR A POST OPERATION FOLLOW UP ON (B)(6) AND COMPLAINED OF LOSS OF VISUAL ACUITY. CT SCAN , BLOOD TEST AND EXAMINATION OF THE FUNDUS WERE CONDUCTED FOR THE PATIENT. VISUAL ACUITY OF THE PATIENT WAS CHECKED AND HAD REDUCED FROM 1.2 TO 0.02. CENTRAL SCOTOMA IN THE FUNDUS HAD APPEARED. ELLEX INC ((B)(4)) HAS REPORTED THE INCIDENT TO (B)(6) . THE DEVICE HAS BEEN INVESTIGATED AND IS FOUND TO BE FUNCTIONING NORMALLY. (B)(6) HAS ACKNOWLEDGED AND CLOSED THE INCIDENT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762146 TANGO OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LT5106-T

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability