BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGO

    MDR report key: 8131816 · Received December 4, 2018

    Report

    Report Number
    3013515803-2018-00013
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    October 5, 2018
    Report Date
    November 14, 2018
    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
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS SOON AS ELLEX LEARNT OF THE EVENT , THE DEVICE PERFORMANCE WAS VERIFIED THROUGH A PRODUCT ACCEPTANCE FAULT RECORD , AND WAS FOUND TO BE COMPLIANT TO SPECIFICATION . THE PHYSICIAN CALLED THE ELLEX REPRESENTATIVE AND CONFIRMED THAT HE USED THE WRONG MODE FOR CAPSULOTOMY (SLT INSTEAD OF YAG) WHICH WAS THE REASON FOR THE PATIENT EYE DAMAGE. ELLEX ALSO VERIFIED THE ADEQUACY OF THE EXISTING DESIGN , LABELLING AND RISK CONTROLS AND THESE WERE DEEMED TO BE ADEQUATE. TANGO CAN OPERATE IN BOTH THE YAG/SLT MODE . AFTER START-UP, SYSTEM ENTERS STANDBY AND USER SHOULD SELECT THE TREATMENT LASER MODE (YAG OR SLT) WHICH IS DISPLAYED ON THE RCU/TABLET. LABELLING EMPHASIZES ON CHECKING THE CORRECT MODE OF OPERATION FOR THE LASER PROCEDURES. THIS IS A FOLLOW UP REPORT . THE PATIENT WAS DOING BETTER FROM THE EARLIER VISIT. HER VISUAL ACUITY REPORTED ON 26TH NOVEMBER,WAS 6/7.5 IN THE INVOLVED EYE BUT SHE STILL DESCRIBED SOME DISTORTION AND A SCOTOMA ON THAT SIDE. SHE SAID IT IS NOT AS "DARK" NOW. SHE DOES HAVE A PIGMENTED SCAR IN THE MACULAR REGION. THE OCT SHOWS THE OVERLYING RETINA TO BE ESSENTIALLY INTACT, WITH MOST OF THE SCAR BEING ASSOCIATED WITH THE RPE.

    Description of Event or Problem · 0

    THIS IS A FOLLOW UP EVENT. THE EVENT OCCURED IN AUSTRALIA, PATIENT HAD A YAG CAPSULOTOMY USING 1.2MJ , 102 SHOTS FOR A THICK PC PLAQUE, EXPERIENCED MACULAR SCARRING AND VISION. LOSS. THIS REPORT IS MADE BY ELLEX WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    AS SOON AS ELLEX LEARNT OF THE EVENT , THE DEVICE PERFORMANCE WAS VERIFIED THROUGH A PRODUCT ACCEPTANCE FAULT RECORD, AND WAS FOUND TO BE COMPLIANT TO SPECIFICATION. THE PHYSICIAN CALLED THE ELLEX REPRESENTATIVE AND CONFIRMED THAT HE USED THE WRONG MODE FOR CAPSULOTOMY (SLT INSTEAD OF YAG) WHICH WAS THE REASON FOR THE PATIENT EYE DAMAGE. ELLEX ALSO VERIFIED THE ADEQUACY OF THE EXISTING DESIGN, LABELLING AND RISK CONTROLS AND THESE WERE DEEMED TO BE ADEQUATE. TANGO CAN OPERATE IN BOTH THE YAG/SLT MODE. AFTER START-UP, SYSTEM ENTERS STANDBY AND USER SHOULD SELECT THE TREATMENT LASER MODE (YAG OR SLT) WHICH IS DISPLAYED ON THE RCU/TABLET. LABELLING EMPHASIZES ON CHECKING THE CORRECT MODE OF OPERATION FOR THE LASER PROCEDURES. THIS REPORT WAS SENT THROUGH THE ESG ON 14TH NOVEMBER; HOWEVER THERE WAS AN ISSUE IN THE RELAY OF THE SUBMISSION, DUE TO THE SIZE OF THE SUPPORTING DATA, A RESUBMISSION IS BEING DONE ON TODAY'S DATE.

    Description of Event or Problem · 1

    THE EVENT OCCURED IN (B)(6), PATIENT HAD A YAG CAPSULOTOMY USING 1.2MJ , 102 SHOTS FOR A THICK PC PLAQUE, EXPERIENCED MACULAR SCARRING AND VISION LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967411 TANGO OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LT5106-T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R