BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPULSE SURGITOUCH 120V DOMESTIC - O.R.

    MDR report key: 17084883 · Received June 8, 2023

    Report

    Report Number
    3020611964-2023-00007
    Event Type
    Injury
    Date Received
    June 8, 2023
    Date of Event
    January 20, 2023
    Report Date
    May 16, 2023
    Manufacturer
    LUMENIS BE LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE LEGAL MANUFACTURER BSCI AND USER FACILITY DIRECTLY. ATTEMPTS BY EMAILS HAVE BEEN MADE TO OBTAIN; TECHNICAL INSPECTION RESULTS AND THE CURRENT STATUS OF THE DEVICE. ULTRAPULSE SURGITOUCH 120V DOMESTIC - O.R. SYSTEM WITH PRODUCT ID: 0642-407-01:014-71668 WAS INSTALLED IN THE FACILITY ON (B)(6) 2008. THIS IS NOW UNDER THE RESPONSIBILITY OF BOSTON SCIENTIFIC CORP. AS THEY HAVE PURCHASED THE SURGICAL DIVISION OF LUMENIS IN 2021. LUMENIS BE LTD. IS NO LONGER CONSIDERED THE LEGAL MANUFACTURER OF THESE DEVICES. AS SUCH, THIS COMPLAINT HAS BEEN TRANSFERRED TO THEM. BSCI HAS OPENED COMPLAINT NUMBER (B)(4). IN THEIR SYSTEM TO HANDLE THIS. HOWEVER, SINCE THIS DEVICE WAS USED FOR AESTHETICAL PROCEDURE, LUMENIS BE TAKING RESPONSIBILITY ON CLINICAL INVESTIGATION OF THIS ADVERSE EVENT. SINCE THE DEVICE IS NOT AVAILABLE FOR EVALUATION BY LUMENIS, BSCI WILL BE RESPONSIBLE FOR HANDLING TECHNICAL ASPECT OF THIS CASE. CLINICAL HEALTH DIRECTOR ADVISED: "PHYSICIAN HAS SUBMITTED AN INCIDENT REPORT INVOLVING THE ULTRAPULSE. DATE OF TREATMENT (B)(6) 2023, DATE OF REPORT (B)(6) 2023. THE INCIDENT REPORT STATES ONLY THE DEEP FX HANDPIECE WAS USED DURING THE CASE. PT IS A 63Y/O FEMALE, FITZPATRICK SKIN TYPE II-III CAUCASIAN. + HISTORY OF SMOKING. NO MEDS OR MEDICAL HISTORY RECORDED. SETTINGS PROVIDED FOR DEEP FX ALONG WITH A PICTURE OF THE U/P SCREEN. 20MJ , SHAPE 2, SIZE 7, 1 PULSE, DENSITY 5, WITH A REPEAT DELAY OF .3SECS. THE HERTZ WERE NOT RECORDED. A PHOTO OF THE U/P SCREEN WAS ALSO ATTACHED WHICH DID NOT SHOW THE HERTZ. PHOTOS OF THE PATIENT IMMEDIATELY POST TREATMENT SHOWED A FEMALE WITH VERY CONCENTRATED SMALL WHITE ATROPHIC WOUND IN THE PERIORAL REGION. IT IS VERY DIFFICULT TO SEE ACTUAL FRACTIONATED CHANNELS IN THESE AREAS. AREA ON THE NOSE AND CHIN SHOW CLEAR ABLATED CHANNELS THAT IN MY OPINION RESEMBLE THE CPG SPOT SIZE WITH ESCHAR AND NOT THE DEEP FX. THE PATIENT WAS TREATED WITH NITRO PASTE, VASELINE, AND SEVERAL PDL TREATMENTS. THIS IS USER ERROR. THE ENDPOINT IS NOT CONSISTENT WITH THE SETTINGS AND HANDPIECE USED. THE PROVIDER SHOULD HAVE STOPPED THIS TREATMENT, RE ASSESSED SETTINGS, ARTICULATING ARM. TESTING ON A DAMP TONGUE DEPRESSOR PRIOR TO TREATMENT IS ALSO RECOMMENDED. IF THE PROVIDER IS UNABLE TO SEE A GOOD ENDPOINT THE PROVIDER SHOULD STOP THE TREATMENT AND SERVICE SHOULD BE CONTACTED. I AM NOT FAMILIAR WITH A SCREEN NOT SHOWING THE HERTZ AND WILL REFER TO BOSTON SCIENTIFIC FOR THIS PART OF THE INVESTIGATION. THE HERTZ CAN PLAY A ROLE IN WHAT I AM SEEING. A FAST RATE MAY HAVE CAUSE DOUBLE PULSES. THE SEVERITY OF THE INJURY RATED TO 6 OUT OF 10; SERIOUS INJURY REQUIRING NON-SURGICAL MEDICAL. THIS DEVICE WAS A SURGICAL DEVICE AND IS PART OF BOSTON SCIENTIFIC. MORE SPECIFIC DETAILS ON THE DEVICE AND HANDPIECE WILL COME FROM THEM". ACCORDING TO THE RECEIVED INFORMATION SERIOUS INJURY CAUSED BY USER ERROR BASED ON INCORRECT TREATMENT. THEREFORE, THIS CASE IS REPORTABLE TO THE FDA. HOWEVER, SINCE NO TECHNICAL INFORMATION WAS PROVIDED NEITHER BY THE LEGAL MANUFACTURER NOR BY THE CUSTOMER, IT'S IMPOSSIBLE TO EVALUATE TECHNICAL STATUS OF THE DEVICE WITHIN 30 DAYS PERIOD WHICH IS DETERMINED FOR REPORTABILITY. ALL THE INFORMATION SENT TO THE LEGAL MANUFACTURER BSCI.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 A COMPLAINT ON THE COMPLICATION WITH ULTRAPULSE SURGITOUCH DEVICE. LATER, THE CUSTOMER SENT PHOTO WITH INJURED AREA OF THE PATIENT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274826 ULTRAPULSE SURGITOUCH 120V DOMESTIC - O.R. CO2 ULTRAPULSE DEVICE GEX LUMENIS BE LTD. ULTRAPULSE SURGITOUCH 120V DOMESTIC - O.R.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other