BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPULSE ENCORE

    MDR report key: 2804890 · Received October 25, 2012

    Report

    Report Number
    3004135191-2012-00057
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 25, 2012
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K022060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE EVENT REPORT CONTACTING THE INITIAL REPORTER BY LETTER AND BY EMAIL TO OBTAIN PATIENT INFORMATION, TREATMENT SETTINGS, SUN EXPOSURE, PHOTOS OF THE ADVERSE OUTCOME, AND INFORMATION ABOUT THE SERIOUSNESS OF THE PATIENT'S ADVERSE REACTION FROM THE INITIAL REPORTER HOWEVER ONLY THE PATIENT'S NAME WAS PROVIDED. LUMENIS USED THE INFORMATION PROVIDED TO DETERMINE THE NAME OF THE USER FACILITY. LUMENIS CONTACTED THE USER FACILITY DIRECTLY TO INVESTIGATE THE EVENT REPORT REQUESTING PATIENT INFORMATION, TREATMENT SETTINGS, AND PHOTOGRAPHS OF THE REPORTED ADVERSE REACTION; HOWEVER NONE WERE PROVIDED. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT NOTED THE MIDDLE JOINT OF THE ARTICULATING ARM WAS LOOSE CAUSING MISALIGNMENT OF THE BEAM IN THE ARM; THEREFORE THE CPG PATTERN WAS NOT ACCURATE. IT WAS FURTHER NOTED THAT THE MIDDLE JOINT OF THE ARTICULATED ARM WAS HITTING THE CEILING OF THE TREATMENT ROOM. A REVIEW OF HISTORICAL SUBJECT DEVICE SERVICE RECORDS FOUND THAT THE DEVICE HAD NOT BEEN SERVICED FOR PREVENTATIVE MAINTENANCE BY LUMENIS SINCE 06/16/2009. A REVIEW OF SUBJECT DEVICE IFU FOUND THAT ANNUAL PREVENTIVE MAINTENANCE BY LUMENIS-CERTIFIED ENGINEER IS RECOMMENDED TO ASSURE THE SAFE OPERATION OF THE SUBJECT DEVICE. "PREVENTATIVE MAINTENANCE, SAFETY, POWER, AND CALIBRATION CHECKS SHOULD BE PERFORMED ANNUALLY BY A LUMENIS-CERTIFIED SERVICE ENGINEER TO ENSURE PROPER LASER PERFORMANCE". ABSENT PATIENT TREATMENT RECORDS AND PHOTOGRAPHS OF THE PATIENT'S ADVERSE REACTION, LUMENIS IS UNABLE TO MAKE A DETERMINATION OF THE APPROPRIATENESS OF SELECTED TREATMENT SETTINGS OR TO DETERMINE A CAUSE FOR THE EVENT. SHOULD ADDITIONAL INFORMATION BE PROVIDED WITH WHICH TO MAKE A DETERMINATION OF CAUSE, LUMENIS WILL FILE A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT A PATIENT SUSTAINED AN ADVERSE TREATMENT REACTION FOLLOWING A PROCEDURE PERFORMED WITH A LUMENIS ULTRAPULSE LASER. NO INFORMATION ABOUT THE SERIOUSNESS OF THE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASER GEX LUMENIS, LTD. ULTRAPULSE ENCORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other