BEUDAMED
    FDA Adverse Event Summary report: N

    OPTICAL INTEGRITY GENERAL SHAPED FIBER

    MDR report key: 2492497 · Received March 15, 2012

    Report

    Report Number
    1720381-2012-00012
    Date Received
    March 15, 2012
    Date of Event
    January 12, 2012
    Report Date
    March 12, 2012
    Manufacturer
    OPTICAL INTERGRITY INC.
    Product Code
    GEX
    PMA / PMN Number
    K022338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT AND DETERMINED THAT THE SUBJECT DEVICE WAS REPORTED ERRONEOUSLY AS A LUMENIS (FORMERLY COHERENT) VP SELECT LASER. THE ACTUAL SUBJECT DEVICE OF THE EVENT REPORT IS A LASER FIBER DELIVERY DEVICE, OPTICAL INTEGRITY GENERAL SHAPED FIBER, MANUFACTURED BY OPTICAL INTEGRITY, INC. LUMENIS DETERMINED THAT THE SUBJECT DEVICE WAS NOT TESTED OR QUALIFIED BY LUMENIS FOR USE WITH ITS LASER SYSTEMS. LUMENIS CONTACTED THE DEVICE MANUFACTURER TO REPORT THE EVENT AND OBTAIN ADDITIONAL DEVICE INFORMATION. NO INFORMATION ABOUT THE MANUFACTURE DATE, LOT NUMBER OR OTHER IDENTIFYING INFORMATION WAS MADE AVAILABLE TO LUMENIS.

    Description of Event or Problem · 1

    IT WAS REPORTED ON MW (B)(4) THAT DURING A LASER LITHOTRIPSY PROCEDURE, A PHYSICIAN SUSTAINED A 1MM BURN TO THE HAND. IT WAS FURTHER REPORTED THAT THE SURGEON SUSTAINED NO IMPAIRMENT AND THAT NO MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTICAL INTEGRITY GENERAL SHAPED FIBER LASER FIBER DELIVERY DEVICE GEX OPTICAL INTERGRITY INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other