BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER QUATTRO

    MDR report key: 12201318 · Received July 21, 2021

    Report

    Report Number
    3004135191-2021-00047
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 21, 2021
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    UDI-DI
    07290109144658
    PMA / PMN Number
    K170179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. ATTEMPTS BY EMAILS AND PHONE CALLS HAVE BEEN MADE TO OBTAIN; PATIENT TREATMENT SETTINGS, PATIENT INFORMATION, PATIENT PHOTO. AN EXAMINATION OF THE SUBJECT DEVICE WAS PERFORMED BY LUMENIS SERVICE ENGINEER AFTER VERIFYING ALL SYSTEM FUNCTIONS INCLUDING COOLANT LEVEL CHECK THAT WAS FOUND AT LOW LEVEL, REFILLED RESERVOIR. ENERGY READINGS REGISTERED HIGH, MORE THAN 20%. PERFORMED POWER METER CALIBRATION. ENERGY READINGS WITHIN SPEC. AFTER RECALIBRATION. CE WASN'T ABLE TO DUPLICATE THE REPORTED PROBLEM. NO DEVICE MALFUNCTION WAS OBSERVED. THE SYSTEM WAS OPERATIONAL AND WAS READY FOR USE. DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. PROBABLY THIS WAS A USER ERROR, THE USER DIDN'T PERFORM A CALIBRATION ON TIME. ACCORDING TO USER MANUAL, CALIBRATION IS REQUIRED WHEN A NEW HANDPIECE IS AUTHORIZED TO OPERATE WITH THE SYSTEM, AND AFTER EVERY CYCLE OF 30,000 PULSES. THIS SYSTEM WAS INSTALLED ON JULY, 28 2020, NO SUCH ISSUE WAS FOUND ACCORDING TO THE SYSTEM HISTORY. PM WAS NOT PERFORMED YET DUE TO NEW SYSTEM, BASED ON SERVICE MANUAL PREVENTIVE MAINTENANCE VISIT SHOULD BE CONDUCTED ONCE A YEAR. CLINICAL EVALUATION WASN'T PERFORMED, SINCE NO INCIDENT FORM OR PHOTOS WERE SENT TO LUMENIS. LUMENIS TRIED SEVERAL TIME TO ACHIEVE MORE INFORMATION DIRECTLY FROM THE CUSTOMER, BUT WITHOUT SUCCESS. ACCORDING TO THE INFORMATION RECEIVED THERE WAS NO DEVICE MALFUNCTION. PROBABLY THIS WAS A USER ERROR, THE USER DIDN'T PERFORM A CALIBRATION ON TIME. BASED ON 1010482 _REV H- QUATTRO FAMILY RISK ANALYSIS MATRIX - MIS-CALIBRATION ( PAR. #2.1.3 AND #2.1.3.1), THE RISK IS WITHIN THE ACCEPTABLE RISK. NO CLINICAL EVALUATION WAS PERFORMED DUE TO LACK OF INFORMATION, ALTHOUGH LUMENIS TRIED TO ACHIEVE MORE INFORMATION FROM THE CUSTOMER. 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 · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101552 LIGHTSHEER QUATTRO SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS LTD. LIGHTSHEER QUATTRO 07290109144658

    Patients

    Seq Age Sex Outcome Treatment
    1 Other