BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL V+

    MDR report key: 14198057 · Received April 25, 2022

    Report

    Report Number
    2954354-2022-00001
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 24, 2022
    Report Date
    April 25, 2022
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K153671
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCEL V+ COOLVIEW HANDPIECE INVOLVED IN THE INCIDENT WAS INSPECTED BY A CUTERA FSE AT THE CUSTOMER'S SITE. THE HANDPIECE IS BEING RETURN TO CUTERA TO BE DISASSEMBLED SO THE ROOT CAUSE OF THE MALFUNCTION CAN BE DETERMINED. THE PATIENT WAS GIVEN SILVER SULFADIAZINE FOR USE BID AND FACTOR 5 GF. 14 DAYS POST, BURNS HAVE HEALED OR ARE "HEALING & GRANULATING ON NECK AND CHEST, AREAS OF SWELLING STILL PRESENT ESPECIALLY AROUND THE EYES" A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN THE DEVICE HAS BEEN RETURNED AND EVALUATED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, AFTER NORMAL BUSINESS HOURS, AN EXCEL V+ CUSTOMER CALLED A CUTERA CLINICAL TRAINER TO REPORT A PATIENT HAD SUFFERED AN ADVERSE EVENT DURING AN EXCEL V+ 532 NM TREATMENT SHE'D PERFORMED THAT DAY ON THE PATIENT'S CHEEKS, NECK, AND UPPER CHEST. ON FRIDAY (B)(6) 2022, SHE SENT AN EMAIL TO THE CLINICAL TRAINER SHE'D CALLED THE PRIOR EVENING WITH 3 ATTACHED PHOTOS (ONE AN IMMEDIATE-POST OPERATIVE PHOTO OF THE PATIENT'S NECK AND UPPER CHEST, AND TWO PHOTOS THE PATIENT HAD TAKEN EARLIER ON THE (B)(6) OF THE AREAS TREATED THE PRIOR DAY). THE CLINICAL TRAINER FORWARDED THE CUSTOMER'S EMAIL AND 3 PHOTOS TO BEGIN THE AE INVESTIGATION. THE IMMEDIATE POST-TREATMENT PHOTO SHOWED NUMEROUS SMALL (<5 MM) GRAY/WHITE BLANCHED SKIN AREAS (DENATURED EPIDERMIS AND/OR FORMING BLISTERS) WITH SIGNIFICANT PERIPHERAL ERYTHEMA AND EDEMA SURROUNDING EACH BLANCHED AREA. THE ~18-HOURS POST-TREATMENT PHOTOS SHOWED THAT MANY OF THE BLANCHED AREAS HAD CRUSTED WITHOUT BECOMING BLISTERS (1ST DEGREE BURNS), SOME HAD DEVELOPED INTO BLISTERS (2ND DEGREE BURNS; WITH A FEW BEING UNROOFED), AND THE BALANCE HAD RESOLVED OR WERE DEVELOPING INTO EPIDERMAL CRUSTS MORE SLOWLY. THE ~18-HOUR POST-TREATMENT PHOTOS ALSO SHOWED FAR LESS PERIPHERAL ERYTHEMA AND EDEMA SURROUNDING EACH CRUST AND/OR BLISTER, AND THE GENERALIZED FACIAL EDEMA TYPICAL SEEN FOLLOWING 532 NM GLOBAL TREATMENTS OF THE FACE (MOST EVIDENT IN THE UPPER CHEEKS JUST BELOW THE EYES). THE CUSTOMER HAD REPORTED A 12 MM SPOT SIZE HAD BEEN USED FOR A TEST SPOT AND A 10 MM SPOT HAD BEEN USED DURING THE FULL TREATMENT; HOWEVER, THE <5 MM SIZES OF THE BURNS WERE INCONSISTENT WITH USING A 10 MM DIAMETER SPOT. THE AE INVESTIGATOR REQUESTED A CUTERA FIELD SERVICE ENGINEER (FSE) BE SENT TO THE SITE TO INSPECT THE SYSTEM AND VERIFY IT WAS CORRECTLY CALIBRATED AND DELIVERING TOP-HAT INTENSITY PROFILE TREATMENT BEAMS. THE FSE VISITED THE SITE ON 3/28/2022 AND FOUND THE DEVICE WAS CORRECTLY CALIBRATED AND DELIVERING TOP-HAT PROFILE BEAMS; HOWEVER, ALSO THAT THE SPOT SIZE WAS NOT CHANGING FROM 4 MM WHEN LARGER SPOT SIZES WERE SELECTED. THE FSE TOLD THE CUSTOMER A REPLACEMENT HANDPIECE WAS BEING SENT, TO NOT TO USE THE DEFECTIVE HANDPIECE, AND TO RETURN IT TO CUTERA USING THE SHIPPING PACKAGING THE REPLACEMENT HANDPIECE WAS DELIVERED IN. THE CUSTOMER HAS NOT YET RETURNED THE DEFECTIVE HANDPIECE FOR EVALUATION DESPITE SEVERAL REQUESTS. DURING FOLLOW-UP CALLS AND IN THE AE QUESTIONNAIRE THE CUSTOMER COMPLETED, THE CUSTOMER REPORTED THAT AFTER DELIVERING A TEST PULSE TO THE PATIENT'S RIGHT CHEEK USING THE SETTINGS SHE'D ORIGINALLY INTENDED FOR THE FULL TREATMENT (532 NM, 7.6 J/CM2, 12-MM SPOT SIZE, 12 MS PULSE DURATION, AND 5°C COOLING WINDOW TEMPERATURE), SHE IMMEDIATELY NOTICED SIGNIFICANT BLANCHING/WHITENING OF THE PATIENT'S SKIN IN THE CENTER OF THE "THEN BELIEVED TO BE" 12-MM DIAMETER TREATMENT SPOT. SHE SAID SHE DIDN'T NOTICE THE SIZE OF BLANCHED SPOT WAS THE SIZE OF THE AIMING BEAM AND THAT THE AIMING BEAM WAS MUCH SMALLER IN DIAMETER THAN THE 12 MM SELECTED. WITH THE PATIENT'S EYES COVERED BY LASER SAFETY GOGGLES AND WANTING TO PROCEED, SHE REDUCED THE FLUENCE TO 5.0 J/CM2 AND THE SPOT SIZE TO 10 MM (SELECTED, BUT UNCHANGED FROM THE 4-MM SIZE OF THE COLINEAR AIMING BEAM) HALVING THE ENERGY DELIVERED EACH PULSE; INCREASED THE PULSE DURATION TO 15 MS (LOWING THE DELIVERED POWER BY 20%); AND KEPT THE COOLING WINDOW TEMPERATURE AT 5°C. SHE FIRED A 2ND TEST PULSE ADJACENT TO THE FIRST, AND AFTER SEEING WHAT WAS STILL A STRONGER THAN EXPECTED SKIN REACTION, BUT LESS SIGNIFICANT THAN THE FIRST TEST PULSE, CHOSE TO USE THESE SETTINGS FOR THE FULL TREATMENT OF THE PATIENT'S CHEEKS, NECK, AND UPPER CHEST. DURING AND IMMEDIATELY AFTER THE TREATMENT, THE PATIENT DEVELOPED EPIDERMAL OR PARTIAL-THICKNESS 4-MM DIAMETER SKIN BURNS IN MOST AREAS THAT RECEIVED LASER TREATMENT PULSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774305 EXCEL V+ DERMATOLOGY LASER GEX CUTERA, INC. EXCEL V+ COOLVIEW HANDPIECE

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other