BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO

    MDR report key: 9914734 · Received April 2, 2020

    Report

    Report Number
    3002806902-2020-00003
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 2, 2020
    Report Date
    April 2, 2020
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    PMA / PMN Number
    K021550
    Removal / Correction Number
    NUMBER NOT AVAILABLE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS SOON AS ELLEX INC (B)(4) (ELLEX MEDICAL SUBSIDIARY IN (B)(4)) WAS NOTIFIED OF THE EVENT, THE DEVICE WAS QUARANTINED AND THE COMPLAINT NOTIFIED TO ELLEX MEDICAL. THE SERVICE TECHNICIAN FOUND THE JOYSTICK WIRE WAS DAMAGED. IT WAS UNDERSTOOD FROM THE COMMUNICATION THAT THE DEVICE WAS PART OF THE RECALL IN 2007 AS PER GLOBAL SERVICE BULLETIN - 07-08.3 TO ADD THE RETAINING CLIP IN THE FIELD, BUT APPARENTLY THE MODIFICATION WAS NOT CARRIED OUT FOR THIS UNIT, AS CONFIRMED BY THE REWORK RECORDS. THE REPORTED "MISFIRING" MUST HAVE OCCURRED WHEN THE DAMAGED WIRE MADE CONTACT WITH THE EARTHED JOYSTICK CHASSIS IN READY MODE. THE COMMUNICATION WITH THE FDA DATED 5TH JULY 2018 HAS NOT INDICATED ANY CONCERNS OF THE EFFECTIVENESS OF THE RECALL. AS PER THE RECALL STRATEGY DETAILED IN THE GLOBAL SERVICE BULLETIN 07/08.3 / 24 AUGUST 2007 FIELD CORRECTION WAS TO BE CONDUCTED AT THE NEXT SERVICE CALL FOR EACH IDENTIFIED SYSTEM. IT IS ASSUMED THAT THE CUSTOMER DID NOT ARRANGE THE PREVENTIVE MAINTENANCE AS THEY SHOULD HAVE, OR THE RECALL WAS PROBABLY FOLLOWED ONLY FOR THE 1ST STAGE , AND IMPLEMENTATION WAS NOT FOLLOWED UP FOR THE 2ND PART OF THE RECALL (AFFIXING OF THE RETAINER CLIP) WHICH EXPLAINS THE REASON FOR THE MISSING RETAINING CLIP FROM THIS UNIT. AS MENTIONED, THERE WAS NO SERIOUS INJURY REPORTED AS THE DEVICE WAS USED FOR IRIDOTOMY AND HAD CAUSED MINOR INJURY TO CORNEAL ENDOTHELIAL CELLS NOT REQUIRING MEDICAL INTERVENTION. HOWEVER, THE HAZARD SEVERITY COULD HAVE BEEN GREATER FOR OTHER TREATMENT PROCEDURES AND THERE COULD HAVE BEEN A POTENTIAL FOR A SERIOUS INJURY REQUIRING MEDICAL INTERVENTION. HENCE ELLEX CONSIDERS IT OBLIGATORY TO REPORT THE INCIDENT. (B)(4).

    Description of Event or Problem · 1

    THE USER REPORTED AN UNINTENDED LASER EMISSION WHEN MOVING THE SLIT LAMP WITH THE JOYSTICK ON A TANGO LASER. THERE WAS MINOR INJURY TO THE CORNEAL ENDOTHELIAL CELLS , WHICH DID NOT IMPACT PATIENT VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380544 TANGO OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LT5106-T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other