BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHSHEER DUET

    MDR report key: 15975595 · Received December 14, 2022

    Report

    Report Number
    3021349626-2022-00006
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    November 24, 2022
    Report Date
    December 14, 2022
    Manufacturer
    LUMENIS BE LTD.
    Product Code
    GEX
    UDI-DI
    07290109140384
    PMA / PMN Number
    K170179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. ATTEMPTS BY EMAILS HAVE BEEN MADE TO OBTAIN, PATIENT TREATMENT SETTINGS, PATIENT INFORMATION, PATIENT PHOTO. THE DEVICE GASB00002:(B)(4) WAS INSTALLED IN THE FACILITY ON (B)(6) 2015 AND THE LAST PM WAS DONE ON (B)(6) 2016. SINCE THEN THE CUSTOMER HASN'T REQUESTED NOR INITIATED PM TO BE DONE BY LUMENIS. IT'S STRONGLY RECOMMENDED BY LUMENIS TO PERFORM PREVENTIVE MAINTENANCE (PM) EARLY AND INITIATING OF THIS ACTIVITY LAYS ON CUSTOMER'S RESPONSIBILITY. SERVICE ENGINEER (CE) VISITED AND TESTED THE DEVICE. CE TESTED THE ET HAND PIECE ENERGY AND EPI COOLING AND FOUND THEM WITHIN ACCEPTABLE LIMITS. THE SYSTEM IS IN PROPER WORKING CONDITION. DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. HOWEVER, CE ADVISED THAT CLINICAL TRAINING OF OPERATORS IS RECOMMENDED. ACCORDING TO THE INFORMATION RECEIVED THERE IS NO MALFUNCTION ON A SYSTEM. HOWEVER, SINCE THE CUSTOMER REFUSED TO DISCLOSE ANY CLINICAL INFORMATION REGARDING INJURY AND SENT US INCIDENT FORM WITH NO PATIENT OR TREATMENT INFORMATION, BUT ONLY DEVICE DESCRIPTION, LUMENIS IS REPORTING GIVEN EVENT TO THE FDA IN AN 'ABUNDANCE OF CAUTION'. ALL RELEVANT INFORMATION WAS SENT TO CHINESE REPRESENTATIVES OF LUMENIS IN ORDER TO DECIDE IF THIS CASE SHOULD BE SUBMITTED FOR APPROVAL TO THE NMPA AS WELL. SHOULD ADDITIONAL SIGNIFICANT INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY LS DUET DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1981029 LIGHSHEER DUET SOLID STATE AESTHECIC LASER DELIVERY DEVICE GEX LUMENIS BE LTD. LIGHTSHEER DUET HS 07290109140384

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other