BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASEREX TANGO

    MDR report key: 619036 · Received June 30, 2005

    Report

    Report Number
    9680659-2005-00001
    Event Type
    Injury
    Date Received
    June 30, 2005
    Date of Event
    May 12, 2005
    Report Date
    June 27, 2005
    Manufacturer
    ELLEX MEDICAL PTY. LTD.
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LASEREX TANGO IS AN OPHTAHALMIC LASER CAPABLE OF DELIVERING EITHER A YAG LASER (1064 NM WAVELENGTH) FOR PHOTODISRUPTION PROCEDURES SUCH AS POSTERIOR CAPSULOTMY OR SLT LASER (532 NM WAVELENGTH) FOR PROCEDURES WITHIN THE TRABECULAR MESHWORK. THE TANGO CAN ONLY BE USED IN ONE MODE AT AT TIME WITH THE SELECTED MODE SHOWN ON THE CONTROL DISPLAY. IN THIS INCIDENT, A CLINICIAN STARTED A LASER CAPSULOTOMY PROCEDURE ON THE PATIENT (REQUIRING A YAG LASER OUTPUT) WHILST THE LASER SET IN THE SLT MODE. ONE SHOT WAS FIRED BEFORE THE ERROR WAS DISCOVERED. THE CLINICIAN WAS UNAWARE THAT THIS MIGHT LEAD TO ANY PROBLEM AND CONTINUED WITH THE CAPSULOTOMY USING THE CORRECT YAG MODE. THE PATIENT RETURNED TO THE HOSPITAL THE NEXT DAY COMPLAINING THAT THEIR SIGHT HAD BEEN EXTREMELY POOR SINCE THE TREATMENT. THE PATIENT'S VISION REMAINS AT <6/60 WITH CLEAR PIGMENTARY SCARRING FO THE MACULAR AREA. THE HOSPITAL HAD DOCUMENTED THE INCIDENT AS A SERIOUS UNTOWARD INCIDENT, MADE A REPORT TO THE NHS AND EXPLAINED TO THE PATIENT AND FAMILY THAT A MISTAKE HAS BEEN MADE. THERE IS NO SUGGESTION THAT THE MANUFACTURER IS A FAULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability