BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM SR

    MDR report key: 2031996 · Received March 28, 2011

    Report

    Report Number
    3004135191-2011-00008
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    April 8, 2009
    Report Date
    March 25, 2011
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K020839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF SERVICE RECORDS FOR THE SUBJECT DEVICE CONCLUDED THE DEVICE HAD BEEN SERVICED REGULARLY AND HAD BEEN EXAMINED AND EVALUATED WITHIN ONE MONTH OF THE REPORTED EVENT DATE AND FOUND TO MEET MANUFACTURER SPECIFICATIONS. THE SUBJECT DEVICE HAD BEEN REGULARLY SERVICED BY A LUMENIS TECHNICAL SPECIALIST ACCORDING TO MANUFACTURER RECOMMENDATIONS. AN EVALUATION OF THE REPORTED TREATMENT PARAMETERS BY A LUMENIS HEALTHCARE PROFESSIONAL CONCLUDED THE PARAMETERS WERE WITHIN ACCEPTABLE GUIDELINES PER DEVICE LABELING AND COMMON MEDICAL PRACTICE CONCLUDING THE PROBABLE ROOT CAUSE OF THE REPORTED EVENT TO BE THE REPORTED DOUBLE-PASS OVER THE AREA BEING TREATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED BURNS AFTER TREATMENT WITH A LUMENIS QUANTUM LASER. IT WAS FURTHER REPORTED BY THE PATIENT THAT DURING THE TREATMENT THE DEVICE OPERATOR WAS INTERRUPTED BY A VISITOR TO THE TREATMENT ROOM AND THAT UPON REINITIATING TREATMENT THE OPERATOR WENT OVER THE SAME AREAS MULTIPLE TIMES. IT WAS FURTHER REPORTED THAT FOLLOW-UP TREATMENTS, CONSTITUTING MEDICAL INTERVENTION, WERE EMPLOYED BY THE FACILITY TO PRECLUDE PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM SR INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS, LTD. SR

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other