BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLELASE PRO U

    MDR report key: 15854922 · Received November 23, 2022

    Report

    Report Number
    0001218402-2022-00004
    Event Type
    Injury
    Date Received
    November 23, 2022
    Report Date
    November 23, 2022
    Manufacturer
    CANDELA CORPORATION
    Product Code
    GEX
    UDI-DI
    00817495020082
    PMA / PMN Number
    K140122
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE NOR EYEWEAR WAS RETURNED TO CADELA. PER FOLLOW UP WITH CANDELA FIELD SERVICE SUPPORT MANAGER IN THE REGION, REGARDING DEVICE, HE ADVISED "AT THIS MOMENT THE SYSTEM IS WORKING AND NO FAULTS AND TECHNICAL ISSUES HAD BEEN DETECTED." CANDELA TECHNICAL SEVICE PROVIDED CUSTOMER WITH DEVICE USER MANUAL, INCLUDING ALL SAFETY INSTRUCTIONS, AND REMINDED CUSTOMER TO "KEEP IN MIND THAT THERE IS GOOD VENTILATION IN THE ROOM, ENOUGH SPACE, USE A MASK AND IF YOU HAVE DOUBTS, WEAR NEW GLASSES." THE USER MANUAL NOTES: USE ONLY SAFETY EYEWEAR WITH AN OPTICAL DENSITY OF GREATER THAN OR EQUAL TO 5.8 FOR 755 NM. SAFETY EYEWEAR THAT IS DESIGNED FOR USE WITH OTHER LASER SYSTEMS MAY NOT PROVIDE ADEQUATE PROTECTION. PLEASE USE THE DUAL WAVELENGTH EYEWEAR SUPPLIED WITH THE SYSTEM. THE CUSTOMER STATED THAT THE INTEGRITY OF THE GOGGLES WAS NOT GOOD. CUSTOMER STATED THAT THE GOGGLES ARE SCRATCHED AND THEY CAN SEE THE REFLECTION OF THE LASER LIGHT FROM THE SIDE, AND ALSO STATED THAT THE GOGGLES ARE APPROXIMATELY SEVEN YEARS OLD. AS A RESULT, THE CLINIC ORDERED AND RECEIVED THREE PAIRS OF GOGGLES WHICH RESOLVED THE ISSUE. THEREFORE, THE MOST PROBABLE CAUSE FOR THIS EVENT CAN BE TRACED TO COMPONENT FAILURE INDICATING THAT THIS IS A RANDOM OR EXPECTED COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. REVIEW OF RISK MANAGEMENT DOCUMENTS DEMONSTRATE THAT THE REPORTED RISK IS CAPTURED AND ASSESSED. NO FURTHER CORRECTIVE ACTIONS REQUIRED FOR THIS COMPLAINT AT THIS TIME. RISK INFORMATION IS THEN SUBJECT TO PERIODIC RISK REVIEWS.

    Description of Event or Problem · 0

    A CUSTOMER IN SPAIN REPORTED THREE (3) STAFF MEMBERS (ESTHETICIANS) AT THE CLINIC HAD STINGING AND ITCHING EYES AFTER OPERATING THE GENTLELASEPRO U LASER.THERE WAS NO IMPACT NOR INJURY RELATED TO ANY PATIENT. PER FOLLOW-UP WITH CUSTOMER OFFICE MANAGER, IT WAS LEARNED THAT THE DEVICE WAS RECEIVED FROM CANDELA WITH APPROPRIATE PROTECTIVE EYEWEAR. HOWEVER, THE CUSTOMER HAS MOVED THE DEVICE BETWEEN CLINIC LOCATIONS.THE REPORTING CLINIC RECEIVED THE GENTLELASEPRO U LASER UNIT IN JULY OF 2022 "WITHOUT NEW PAIRS OF GOGGLES, SO THEY WERE USING OLD ONES." ADDITIONAL FOLLOW-UP INFORMATION WAS OBTAINED FROM THE CLINIC OFFICE MANAGER/ESTHETICIAN, INDICATING THAT THE EYE STINGING AND ITCHING "FIRST HAPPENED DURING JULY." SPECIFIC DATE IS UNKNOWN. CUSTOMER REPORTED THAT THEY THEN STOPPED WORKING DURING THE SUMMER TIME. THE OFFICE MANAGER SAID IT OCCURRED AGAIN ONCE THEY STARTED WORKING WITH THE LASER AGAIN, APPROXIMATELY 15 DAYS PRIOR TO REPORTING TO CANDELA. TWO REGULAR OPERATORS OF THE DEVICE HAVE BEEN IMPACTED. THE OFFICE MANAGER DOESN'T WORK HABITUALLY WITH THE LASER BUT REPORTED SHE EXPERIENCED THE SAME WHEN SHE COVERED FOR THE TWO OPERATORS WHEN THEY WERE AWAY ON HOLIDAYS. THE OFFICE MANAGER REPORTED BEING TREATED WITH CORTICOSTEROIDS FOR THE EYES, AND EXPECTED TO HEAL.THERE WAS NO REPORTED MEDICATION USED BY THE OTHER TWO LASER OPERATORS, BOTH EXPECTED TO HEAL. THE OFFICE MANAGER REPORTED THAT THE GOGGLES USED WERE APPROPRIATE FOR THE WAVELENGTH AND PROVIDED A PHOTO NOTING COVERAGE OF 755 NM WAFVELENGTH ON THE GOGGLE LENS. THE OFFICE MANAGER ALSO CONFIRMED THAT THE INTEGRITY OF THE GOGGLES WAS NOT GOOD, AND EXPLAINED THAT THE GOGGLES ARE SCRATCHED AND THEY CAN SEE LASER LIGHT FROM THE SIDE. SHE ALSO REPORTED THAT SHE THINKS THE GOGGLES USED WERE SEVEN (7) YEARS OLD. THE AVAILABLE DETAILS WERE DISCUSSED WITH CANDELA MEDICAL DIRECTOR. ALTHOUGH IT WAS REPORTED THAT THE STAFF MEMBERS WERE EXPECTED TO HEAL, IT IS UNCLEAR IF THE ITCHING/STINGING ONLY OCCURRED WHEN DIRECTLY WORKING WITH THE LASER AND QUICKLY RESOLVED EACH TIME THEREAFTER; OR IF THERE WAS RESOLUTION FROM INITIAL JULY IMPACT, OR HOW LONG THE REPORTED SYMPTOMS LASTED. THERE IS NO CURRENT UNDERSTANDING IF THE REPORTED ISSUES ARE RESOLVED OR ONGOING. AS IT ISUNCLEAR IF THERE IS ANY PERMANENT DAMAGE, CANDELA IS ERRING ON THE SIDE OF CAUTION AND REPORTING THIS EYE-RELATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362569 GENTLELASE PRO U GENTLELASE PRO U GEX CANDELA CORPORATION 9914-00-9030 00817495020082

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other