BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTA DUET (ELLEX)

    MDR report key: 3746577 · Received April 11, 2014

    Report

    Report Number
    1720381-2014-00024
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    March 4, 2014
    Report Date
    April 11, 2014
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K021550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE EVENT REPORT CONTACTING THE USER FACILITY TO REQUEST PATIENT TREATMENT RECORDS AND OTHER RELEVANT EVENT INFORMATION. THE PATIENT'S TREATMENT SETTINGS WERE PROVIDED. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE SYSTEM PERFORMED TO REQUIRED MANUFACTURER SPECIFICATIONS. NO RELATED DEVICE MALFUNCTION WAS OBSERVED. SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED CAUSED OF THE REPORTED EVENT. A LUMENIS MEDICAL DIRECTOR REVIEWED THE PATIENT'S TREATMENT WITH THE PHYSICIAN CONCLUDING THE INFORMATION OBTAINED POST-OPERATIVELY IS CONSISTENT WITH MILD LASER BURNS ON THE FOVEA. THE LOCATION, IN DIRECT LINE WITH THE VISUAL AXIS AND LASER APERTURE, SUGGESTS THAT THE DEVICE WAS IN SLT MODE WHEN THE LASER WAS FIRED. LACK OF ABILITY TO DESCRIBE CONVERGING AIMING BEAMS, UNIT PARAMETER SETTING (2 MJ, SINGLE BURST), NO OPTICAL BREAKDOWN AND OTHER FACTORS FITTING A YAG LASER BURST FURTHER SUPPORT OUR SUPPOSITION OF USER ERROR IN LASER MODE SELECTION (SLT INSTEAD OF YAG). FINALLY, THE FACT THAT THE DEVICE WAS THOROUGHLY CHECKED DURING ROUTINE MAINTENANCE 4 MONTHS PRIOR TO THE INCIDENT SUGGESTS NO FAULT OF SUBJECT LASER DEVICE.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A MALE PATIENT SUSTAINED A RETINAL BURN TO THE RIGHT EYE FOLLOWING A YAG CAPSULOTOMY WITH A LUMENIS SELECTA DUET LASER. THE REPORTING PHYSICIAN STATED PATIENT'S VISUAL ACUITY DECREASED FROM 20/30 TO 20/400. IT WAS FURTHER REPORTED THAT THE PATIENT SOUGHT MEDICAL ADVICE FROM A RETINAL SPECIALIST NOT ASSOCIATED WITH THE TREATING FACILITY AS FOLLOW-UP INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220419 SELECTA DUET (ELLEX) ND:YAG PHOTOCOAGULATOR GEX LUMENIS, INC. SELECTA DUET (ELLEX)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other