BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTA TRIO

    MDR report key: 2993694 · Received March 7, 2013

    Report

    Report Number
    1720381-2013-00023
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 15, 2013
    Report Date
    March 7, 2013
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K081704
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION WAS REPORTED; THEREFORE NO EXAMINATION OF THE SUBJECT DEVICE OCCURRED. SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED ROOT CAUSE OF THE EVENT REPORTED. A REVIEW OF SUBJECT DEVICE LABELING FOUND THE FOLLOWING PRECAUTIONARY STATEMENTS: LASER MODE - "THE REMOTE CONTROL SCREEN WILL CHANGE TO REFLECT ALL OF THE TREATMENT SETTINGS AVAILABLE IN THE SELECTED LASER MODE." VERIFY THE LASER AIMING BEAM ACCURACY - SLT - "WARNING - VERIFYING THE AIMING BEAM IS EXTREMELY IMPORTANT FOR THE SAFE OPERATION OF YOUR LASER EQUIPMENT. DO NOT USE THE LASER IF THE AIMING BEAM IS NOT VISIBLE. ENSURE THAT IT IS A CLEAR CIRCULAR SHAPE, WITH NO PART OF THE BEAM MISSING. OPERATING THE LASER WITHOUT THE AIMING BEAM OR WITH A POOR AIMING BEAM MAY RESULT IN LASER EXPOSURE TO NON-TARGET TISSUE AND POSSIBLE INJURY. WARNING - CORRECT OPTICAL ALIGNMENT IS CRITICAL FOR ACCURATE AIMING OF THE EQUIPMENT. THIS PRE-OPERATIVE PROCEDURE SHOULD BE PERFORMED DAILY." VERIFY THE LASER AIMING BEAM ACCURACY - YAG - "WARNING - VERIFYING THE AIMING BEAM IS EXTREMELY IMPORTANT FOR THE SAFE OPERATION OF YOUR LASER EQUIPMENT. DO NOT USE THE LASER IF THE AIMING BEAM IS NOT VISIBLE. OPERATING THE LASER WITHOUT THE AIMING BEAM MAY RESULT IN LASER EXPOSURE TO NON-TARGET TISSUE AND POSSIBLE INJURY. WARNING - CORRECT OPTICAL ALIGNMENT IS CRITICAL FOR ACCURATE AIMING OF THE EQUIPMENT. THIS PRE-OPERATIVE PROCEDURE SHOULD BE PERFORMED DAILY." (B)(4): NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A JUNIOR DOCTOR ATTEMPTED A YAG CAPSULOTOMY WHILE THE LUMENIS SELECTA TRIO LASER WAS SET IN SLT MODE. IT WAS FURTHER REPORTED THAT THE DOCTOR REALIZED THE ERROR, CHANGED THE MODE TO YAG AND COMPLETED THE PROCEDURE. THE PATIENT REPORTEDLY SUSTAINED SIGNIFICANT SCOTOMA. VISUAL ACUITY IS REPORTED TO HAVE CHANGED FROM 6/12 TO 6/9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97335 SELECTA TRIO SURGICAL LASER DELIVERY DEVICE GEX LUMENIS, INC. SELECTA TRIO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other