Elite iQ M122B1Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08057017760450), received between Sep 21, 2021 and Nov 25, 2025 — classified as 25 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IN DATE (B)(6) 2025 WE RECEIVE A COMMUNICATION FROM THE US IMPORTER, CYNOSURE, RELATIVE TO AN ADVERSE EVENT IN WHICH A PATIENT DEVELOPED BURNS FOLLOWING A HAIR REMOVAL TREATMENT, ON THE LEGS, WITH THE DEVICE ELITE IQ. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ, MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA, MARKETED IN THE USA WITH 510(K) K193426. THE EVENT TOOK PLACE AT (B)(6). THE PATIENT COMPLAINED WITH THE CLINIC ABOUT BURS THAT HAVE DEVELOPED ON THE TREATMENT AREA (LEGS) FOLLOWING THE HAIR REMOVAL TREATMENT. THE US IMPORTER, FOLLOWING THE INITIAL COMMUNICATION, PROCEED TO GATHER MORE DETAILED INFORMATION ABOUT THE EVENT. THE OPERATOR WHO PERFORMED THE TREATMENT ADMITTED THAT THE PATIENT WENT TO A VACATION IN (B)(6) AND THE TREATMENT AREA WAS STILL TANNED. OPERATOR REPORTED TO HAVE STARTED THE TREATMENT WITH THE YAG LASER SOURCE THEN CHANGED TO ALEX. ALEX LASER SOURCE IS NOT THE PROPER WAVELENGTH TO BE USED ON DARKER SKIN TYPES (SUCH AS TANNED SKIN). PARAMETERS USED FOR THE TREATMENT WERE: ALEX LASER SOURCE (755 NM), 15J/CM2, 20MS WITH 18MM HANDPIECE WITH ONE PASS. THE PATIENT WAS PRESCRIBED WITH BIAFINE CREAM AS PREVENTATIVE POST-TREATMENT CARE. PICTURES OF THE

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 23643346 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN DATE SEPTEMBER THE 4TH 2025, WE RECEIVE A COMMUNICATION FROM THE US IMPORTER, CYNOSURE, RELATIVE TO AN ADVERSE EVENT IN WHICH A PATIENT DEVELOPED BURNS FOLLOWING A VASCULAR TREATMENT, ON THE FACE, WITH THE DEVICE ELITE IQ. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ, MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA, MARKETED IN THE USA WITH 510(K) K193426. THE EVENT TOOK PLACE AT (B)(6), USA. PATIENT WAS GIVEN AQUAPHOR, BACITRACIN, AND PREDNISONE AS PREVENTATIVE MEDICATION POST TREATMENT. THE PATIENT WAS TREATED ON THE FOREHEAD, BETWEEN THE EYEBROWS FOR HAIR REMOVAL AND FOR VASCULAR TREATMENT ON THE NOSE. THE TREATMENT PARAMETERS HAS BEEN FOUND TO BE THE FOLLOWING: 1064NM ND: YAG 12 MM SPOT 30JCM2 20MS FOR THE HAIR REMOVAL IN BETWEEN THE EYEBROWS AND 2.5 MM, 120 J/CM2, 30MS FOR THE VASCULAR TREATMENT PERFORMED ON THE NOSE. THE OPERATOR WHO PERFORMED THE TREATMENT REPORTED THAT THE COOLER (ZIMMER) HOSE DID NOT CONNECT PROPERLY. PICTURES OF THE LESIONS REPORTED BY THE PATIENT HAS BEEN SHARED AND REVIEWED BY BOTH THE US IMPORTER'S CLINICAL STAFF AS WELL AS OURS (AS MANUFACTURER OF THE DEVICE). THE LESION HAS BEEN EVALUATED AS A SERIOUS INJURY BECAUSE THEY MAY REQUIRE ME

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 23568034 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A BURN ON THE FOREHEAD AND NOSE FOLLOWING A TREATMENT USING ELITE IQ. PATIENT WAS GIVEN AQUAPHOR, BACITRACIN, AND PREDNISONE AS PREVENTATIVE MEDICATION POST TREATMENT. SETTINGS ON FOREHEAD BETWEEN BROWS WAS LHR 1064NM YAG 12MM SPOT 30JCM2 20MS, AND ON THE NOSE WAS 2.5MM 120 J/CM2 30MS. OPERATOR ALSO NOTED ZIMMER HOSE WAS NOT CONNECTING PROPERLY AND WANTED A DEVICE EVALUATION. A SERVICE EVALUATION WAS PERFORMED WITH CYNOSURE FIELD SERVICE ENGINEER (FSE) CONFIRMING ZIMMER HOSE AT HANDPIECE END WAS DAMAGED AND BEING HELD TOGETHER BY TAPE. THE TAPE WAS SQUEEZING THE ZIMMER HOSE AND COULD BE RESTRICTING AIRFLOW AND AFFECTING THE SKIN COOLING EFFICIENCY. FSE RELAYED TO SITE THAT HOSE SHOULD HAVE BEEN REPLACED. POWER OUTPUT WAS CONFIRMED TO BE WITHIN SPECIFICATION AND WAS NOT THE REASON FOR THE BURNS EXPERIENCED. CYNOSURE CLINICAL REACHED OUT TO THE SITE FOR ADDITIONAL INFORMATION. IMAGES OF THE PATIENT WAS ALSO PROVIDED AND SHOWED PATIENT MAY HAVE RECEIVED POTENTIAL SUN EXPOSURE BEFORE OR AFTER TREATMENT. SITE ALSO RELAYED THAT ONE OF THE TREATMENTS WAS PERFORMED WITH TOO MUCH OVERLAP. PER CYNOSURE CLINICAL, "IT IS UNKNOWN IF OVERLAP CONTRIBUTED

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 23368494 ↗
• InjuryOct 22, 2025Use of Device Problem; Use of Device Problem

  IN DATE (B)(6) 2025 WE RECEIVE A COMMUNICATION FROM THE US IMPORTER, (B)(4), RELATIVE TO AN ADVERSE EVENT IN WHICH A PATIENT DEVELOPED BLISTERS AND SCABBING FOLLOWING A VASCULAR TREATMENT, ON THE FACE, WITH THE DEVICE ELITE IQ. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ, MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA, MARKETED IN THE USA WITH 510(K) K193426. THE EVENT TOOK PLACE AT NATURAL SKIN & SOLE WELLNESS PLACE IN (B)(6). THE CLINIC INFORMED THAT THE PATIENT REACHED BACK AFTER 1/2 DAYS POST TREATMENT COMPLAINING OF BLISTERS AND SCABBING. IN A LATER FOLLOW UP IT IS REPORTED THAT THE PATIENT HEALED WITH DIVOTS IN SOME OF THE AREAS WHERE THE SCABBING WAS. PICTURES OF THE LESIONS REPORTED BY THE PATIENT HAS BEEN SHARED AND REVIEWED BY BOTH THE US IMPORTER'S CLINICAL STAFF AS WELL AS OURS (AS MANUFACTURER OF THE DEVICE). ALSO, TREATMENT PARAMETERS WERE GATHERED BY THE US IMPORTER IN ORDER TO PERFORM INVESTIGATION ON THE EVENT. THE LESION HAS BEEN EVALUATED AS A SERIOUS INJURY BECAUSE THEY MAY REQUIRE MEDICAL ATTENTION TO PREVENT A PERMANENT IMPAIRMENT. (B)(4), AS US IMPORTER OF THE DEVICE, HAVE ALREADY REPORTED THIS CASE TO THE US FDA WITH A DEDICATED MDR REPORT CODE

  Patient problems: Blister; Burn(s)

  MAUDE report 23355332 ↗
• MalfunctionSep 16, 2025Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IN DATE 20/08/2025 WE RECEIVE A COMMUNICATION FROM THE US IMPORTER, CYNOSURE, RELATIVE TO A MALFUNCTION IN WHICH A CLINIC COMPLAINT OF THE DEVICE FIRING WITHOUT ANY INTERVENTION (ARO) WITH THE DEVICE ELITE IQ. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ, MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA, MARKETED IN THE USA WITH 510(K) K193426. THE CLINIC SEV LASERS (USA) REPORTED TO THE US IMPORTER THAT THE DEVICE WAS FIRING WITHOUT ANY INTERVENTION BY THE USER. THE US IMPORTER CONTACTED THE CLINIC WHICH STATED THAT NO PERSON WERE INJURED DURING THE MISFIRING OF THE DEVICE. CYNOSURE, AS US IMPORTER OF THE DEVICE, HAVE ALREADY REPORTED THIS CASE TO THE US FDA WITH A DEDICATED MDR REPORT CODE MDR1222993-2025-00028 IN DATE AUGUST THE 25TH, 2025. BASED ON THAT, IN ACCORDANCE WITH 21 CFR PART 803.50(B)(2) WE AS MANUFACTURER OF THE DEVICE ARE OBLIGED TO SUBMIT OUR OWN REPORT TO THE FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062207 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED BLISTERS AND IRRITATION FOLLOWING HAIR REMOVAL TREATMENT USING ELITE IQ. BLISTERS WERE CAUSED BY SECOND DEGREE BURN. CYNOSURE CLINICAL TEAM INVESTIGATED THE EVENT AND DETERMINED IT WAS INCONCLUSIVE. PARAMETERS USED WERE WITHIN THE GUIDELINES. SITE RELAYED PATIENT'S PREVIOUS TREATMENTS RESULTED IN A PRONOUNCED HISTAMINE RESPONSE, BUT THIS TREATMENT WAS EVEN MORE PRONOUNCED. PATIENT MENTIONED SHE TOOK COLD BATHS WHEN TREATMENT AREA FELT HOT. CYNOSURE CLINICAL STATES, "WARM OR HOT BATHS CAN CONTRIBUTE TO ADVERSE RESPONSES. IT IS UNKNOWN IF THE BATH WAS WARMER THAN IT SHOULD HAVE BEEN." PATIENT APPLIED HYDROCOSTIONE POST TREATMENT AS PREVENTATIVE MEDICATION. PATIENT ALSO INFORMED SITE THEY VISITED A BURN CLINIC ON (B)(6) 2025, AND TREATMENT AREA WAS DEBRIDED. CYNOSURE ASSISTANT MEDICAL DIRECTOR REVIEWED THE IMAGES PROVIDED AND CONFIRMS PATIENT HEALING APPROPRIATELY WITHOUT INFECTION, BUT IT IS UNKNOWN IF THERE WILL BE A PERMANENT INJURY. CYNOSURE FIELD SERVICER ENGINEER (FSE) ARRIVED ON SITE AND EVALUATED THE DEVICE. FSE CONFIRMED DEVICE WAS OPERATING AS INTENDED WITHIN SPECIFICATION. BLISTERS AND BURNS ARE EXPECTED SIDE EFFECTS FROM SUCH TREATM

  Patient problems: Blister; Partial thickness (Second Degree) Burn

  MAUDE report 23016681 ↗
• MalfunctionAug 25, 2025Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT THE ELITE IQ WAS FIRING INTERMITTENTLY ON ITS OWN. CYNOSURE CLINICAL CONFIRMED THERE WERE NO INJURIES. CYNOSURE FIELD SERVICE ENGINEER (FSE) ARRIVED ON SITE AND EVALUATED THE DEVICE. FSE FOUND CABLES HAVE GONE BAD ON THE HANDPIECES. FSE HAD A SPARE CABLE AND USED IT TO CORRECT THE ISSUE. DUE TO THE SITE REPORTING THAT THE DEVICE WAS FIRING ON ITS OWN, THIS EVENT IS AN ARO (ACCIDENTAL RADIATION OCCURRENCE) AND THEREFORE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22889318 ↗
• InjuryAug 4, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IN DATE JULY THE 23RD 2025 WE RECEIVE A COMMUNICATION FROM THE US IMPORTER, CYNOSURE, RELATIVE TO AN ADVERSE EVENT IN WHICH A PATIENT DEVELOPED BURNS ON THE LEG FOLLOWING A VASCULAR TREATMENT WITH THE DEVICE ELITE IQ. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ, MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA, MARKETED IN THE USA WITH 510(K) K193426. PICTURES OF THE LESIONS REPORTED BY THE PATIENT HAS BEEN SHARED AND REVIEWED BY BOTH THE US IMPORTER'S CLINICAL STAFF AS WELL AS OURS (AS MANUFACTURER OF THE DEVICE). THE LESION HAS BEEN EVALUATED AS A SERIOUS INJURY BECAUSE THEY MAY REQUIRE MEDICAL ATTENTION TO PREVENT A PERMANENT IMPAIRMENT. THE TREATMENT WAS PERFORMED IN DATE (B)(6) 2025 WHILE THE PATIENT EXPERIENCED THE ADVERSE EFFECTS APPROXIMATELY 5 WEEKS FOLLOWING THE TREATMENT. PARAMETERS USED FOR THE TREATMENT HAS BEEN SHARED AS WELL THAT ARE: 120J/CM2 WITH 5MM HANDPIECE WITH PULSE DURATION EQUAL TO 10MS. IT IS NOTED THE PRESENCE OF A 10% OVERLAPPING IN THE SHOTS. THE PATIENT WAS PRESCRIBED WITH MUPIROCIN AND MOMETASONE AS PREVENTATIVE MEDICATION. CYNOSURE, AS US IMPORTER OF THE DEVICE, HAVE ALREADY REPORTED THIS CASE TO THE US FDA WITH A DEDICATED MDR REPORT CODE

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 22699314 ↗
• InjuryJul 29, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IN DATE JULY THE 1ST 2025, WE RECEIVE A COMMUNICATION FROM THE US IMPORTER, CYNOSURE, RELATIVE TO AN ADVERSE EVENT IN WHICH A PATIENT DEVELOPED BURNS, SORES AND CRUSTING ON THE LEG FOLLOWING A VASCULAR TREATMENT WITH THE DEVICE ELITE IQ. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ, MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA, MARKETED IN THE USA WITH 510(K) K193426. PICTURES OF THE LESIONS REPORTED BY THE PATIENT HAS BEEN SHARED AND REVIEWED BY BOTH THE US IMPORTER'S CLINICAL STAFF AS WELL AS OURS (AS MANUFACTURER OF THE DEVICE). THE LESION HAS BEEN EVALUATED AS A FULL THICKNESS BURNS ON THE LEGS WHICH MAY REQUIRE MEDICAL ATTENTION TO PREVENT A PERMANENT IMPAIRMENT. PICTURES WERE TAKEN 13 DAYS POST TREATMENT. DESPITE THE SEVERITY OF THE LESIONS THEIR EXTENSION IS LIMITED. PARAMETERS USED FOR THE TREATMENT HAS BEEN SHARED AS WELL THAT ARE: 135J/CM2 WITH 5MM HANDPIECE WITH PULSE DURATION EQUAL TO 15MS. US IMPORTER STATED TO HAVE REACHED TO THE CLINIC NUMEROUS TIMES IN ORDER TO GATHER MORE DETAILED INFORMATION BUT THE SITE WAS UNWILLING TO SHARE SUCH INFORMATION. THE PATIENT WAS PRESCRIBED WITH ALOE AS PREVENTATIVE AS POST-TREATMENT CARE. CYNOSURE, AS US IMPORTER OF T

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 22640729 ↗
• InjuryJul 25, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SITE REPORTED PATIENT EXPERIENCING SIDE EFFECTS APPROXIMATELY FIVE (5) WEEKS POST VASCULAR TREATMENT ON THE LEGS USING ELITE IQ PRO. (B)(6) CLINICAL DETERMINED THE EVENT TO BE USER ERROR. LASER PARAMETERS USED WERE WITHIN NORMAL RANGE, HOWEVER THE SHORT PULSE DURATION OF 10MS WAS NOT APPROPRIATE FOR THE BLOOD VESSELS VISIBLE IN THE PRE-TREATMENT IMAGES. CLINICAL REFERENCE GUIDE (CRG) RECOMMENDS, "PULSE DURATION OF 50-10 MS FOR SAFER AND MORE EFFECTIVE TREATMENT OF LARGER VESSELS." CLINICAL EXPRESSES, "PULSES SHOULD BE DELIVERED IN A LINEAR FASHION WITH LESS THAN 10% OVERLAP." THE TREATMENT PERFORMED HAD APPROXIMATELY 10% OVERLAP. CRG ADVISES USING CONDUCTIVE GEL AS A CONDUIT FOR LASER ENERGY, BUT NO COATING GEL WAS USED. CRG RECOMMENDS "USE OF COLD PACKS (NOT ICE) BOTH BEFORE AND AFTER TREATMENT, ESPECIALLY FOR LARGER VEINS." PATIENT HAS A HISTORY OF VARICOSE VEINS, WHICH RAISES CONCERNS ABOUT HER SUITABILITY FOR THIS TYPE OF TREATMENT. IT REMAINS UNCLEAR WHETHER THE SIDE EFFECTS WERE EXACERBATED BY HER 8-9 HOUR FLIGHT FOUR DAYS AFTER HER SECOND SESSION OR BY ANY POSSIBLE SUN EXPOSURE TO THE TREATED AREA. ON 27 JUNE 2025, (B)(6) MEDICAL DIRECTOR WAS CONSULTED FOR FEEDBACK REGARDING

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 22609399 ↗
• InjuryJul 2, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED THAT PATIENT EXPERIENCED BURNS, SORES, AND CRUSTING ON THE LEG FOLLOWING A LEG VEIN TREATMENT USING ELITE IQ. (B)(6) CLINICAL REVIEWED THE EVENT AND DETERMINED IT WAS DUE TO USER ERROR. (B)(6) CLINICAL AFFIRMS, "PROVIDER USED AGGRESSIVE SETTINGS THAT IN MY ASSESSMENT LED TO THE ADVERSE REACTION. THE PROVIDER USED 15MS AND 135J/CM2. THE CLINICAL REFERENCE GUIDE (CRG) RECOMMENDATIONS ARE 50-10MS AND 120-180. THE PROVIDER SHOULD HAVE USED TEST SPOTS STARTING AT LESS THEN AGGRESSIVE 50MS AND 120J/CM2. THE SITE DID NOT GIVE ME ALL THE DETAILS AFTER NUMEROUS ATTEMPTS, HOWEVER STILL AGGRESSIVE SETTINGS LEADING TO RESPONSE." CRG INSTRUCTS, "IMMEDIATELY FOLLOWING TREATMENT, THE AREA MAY APPEAR FLUSHED AND WARM, BUT THERE SHOULD BE NO BRUISING. LARGER VEINS MAY REQUIRE A LONGER PULSE DURATION AND A LARGER SPOT SIZE TO INCREASE DEPTH OF PENETRATION." CRG ALSO WARNS, "TREATING WITH EXCESSIVE ENERGY LEVELS CAN RESULT IN ADVERSE EFFECTS, SUCH AS ABNORMAL PIGMENTATION AND SCARRING." ON (B)(6) 2025, (B)(6) MEDICAL DIRECTOR WAS CONSULTED FOR FEEDBACK REGARDING INFORMATION AND PHOTOS PROVIDED BY SITE. (B)(6) MEDICAL DIRECTOR DECLARES, "I SEE EVIDENCE OF FULL THICKNESS TISSUE LOSS FRO

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 22387351 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN DATE (B)(6) 2025 WE RECEIVE A COMMUNICATION FROM THE US IMPORTER, CYNOSURE, RELATIVE TO AN ADVERSE EVENT IN WHICH A PATIENT DEVELOPED SCARS FOLLOWING A HAIR REMOVAL TREATMENT ON THE FACE WITH THE DEVICE ELITE IQ. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ, MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA, MARKETED IN THE USA WITH 510(K) K193426. IN THE NARRATIVE PROVIDED IS REPORTED THE FOLLOWING: IT WAS REPORTED THAT PATIENT EXPERIENCED A BURN ON THE UPPER LIP AND CHEEK FOLLOWING A LASER HAIR REMOVAL TREATMENT USING ELITE IQ. CYNOSURE CLINICAL REVIEWED THE EVENT AND DETERMINED IT WAS INCONCLUSIVE. SITE FAILED TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE INCIDENT DESPITE CLINICAL'S MULTIPLE REQUESTS FOR PATIENT AND TREATMENT DETAILS. CYNOSURE, AS US IMPORTER OF THE DEVICE, HAVE ALREADY REPORTED THIS CASE TO THE US FDA WITH A DEDICATED MDR REPORT CODE MDR 1222993-2025-00007 IN DATE (B)(6) 2025. BASED ON THAT, IN ACCORDANCE WITH 21 CFR PART 803.50(B)(2) WE AS MANUFACTURER OF THE DEVICE ARE OBLIGED TO SUBMIT OUR OWN REPORT TO THE FDA.

  Patient problems: Scar Tissue

  MAUDE report 21863625 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED A BURN ON THE UPPER LIP AND CHEEK FOLLOWING A LASER HAIR REMOVAL TREATMENT USING ELITE IQ. CYNOSURE CLINICAL REVIEWED THE EVENT AND DETERMINED IT WAS INCONCLUSIVE. SITE FAILED TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE INCIDENT DESPITE CLINICAL'S MULTIPLE REQUESTS FOR PATIENT AND TREATMENT DETAILS. ON 24 FEB 2025, CYNOSURE CLINICAL WAS UPDATED WITH ADDITIONAL INFORMATION AND PHOTOS OF THE PATIENT. CYNOSURE MEDICAL DIRECTOR REVIEWED THE IMAGES AND STATES, "THE NEW IMAGE REVEALS A THICKENED AREA OF HYPERTROPHIC SCAR, SECONDARY TO THE BURN. RECOMMENDATIONS FOR TREATMENT ARE MASSAGE, SILICONE TOPICAL, AND NON ABLATIVE FRACTION LASER OR MICRO NEEDLING." THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATING AS INTENDED WITHIN SPECIFICATION. ROOT CAUSE AS TO WHY THE PATIENT SUSTAINED A BURN/SCARRING IS UNKNOWN SINCE THERE IS INSUFFICIENT INFORMATION AT THIS TIME. CYNOSURE WILL CONTINUE TO MONITOR SUCH COMPLAINTS. BURNS ARE AN EXPECTED SIDE EFFECT FROM SUCH TREATMENT. AS SCARRING POST TREATMENT WAS REPORTED FROM THE EVENT, THIS IS CONSIDERED A PERMANENT INJURY AND THEREFORE REPORTABLE.

  Patient problems: Scar Tissue

  MAUDE report 21699488 ↗
• MalfunctionAug 6, 2024Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  ON JULY THE 19TH, 2024, EL. EN. ELECTRONIC ENGINEERING SPA RECEIVED A COMMUNICATION FROM THE US IMPORTER CYNOSURE OF A MALFUNCTION, WITH THE DEVICE ELITE IQ, IN WHICH THE CUSTOMER COMPLAINTS OF THE DEVICE DOUBLE PULSING AND FOOTSWITCH WORKING INTERMITTENTLY. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ LASER MEDICAL DEVICE (REF: M122B1, S/N: (B)(6)) THAT IS MARKETED IN THE US WITH 510(K) NUMBER K193426 IN THE ABOVE-MENTIONED COMMUNICATION IS REPORTED THE FOLLOWING: CYNOSURE REPORTED THAT THE CLINIC WAS COMPLAINING ABOUT THE DEVICE IN WHICH THE FOOT PEDAL DID NOT WORK PROPERLY AND SOMETIMES DOUBLE PULSES. IN THE COMMUNICATION IS REPORTED THAT NO PATIENT NOR OPERATOR REPORTED ANY INJURY DUE TO THIS MALFUNCTION. THE EVENT TOOK PLACE AT THE LOOK LAB PLACED IN (B)(6). THE PRESENT EVENT HAS BEEN EVALUATED AS A REPORTABLE DUE TO THE FACT THAT THE EVENT REPRESENT AN ACCIDENTAL RADIATION OCCURRENCE (ARO). MOREOVER, THE US IMPORTER, CYNOSURE, PROCEEDED TO SUBMIT THEIR OWN MDR REPORT CODE MDR1222993-2024-00040 IN DATE JULY THE 26TH, 2024. WE THE MANUFACTURER OF THE DEVICE PROCEEDED TO SUBMIT OUR OWN MDR REPORT, IN ACCORDANCE WITH 21 CFR PART 803.50(2) IN ORDER TO SUPPLY ANY MISSING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19916993 ↗
• MalfunctionJul 26, 2024Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED BY THE CUSTOMER THAT THE ELITE IQ FOOT PEDAL WAS INTERMITTENT AND DOUBLE PULSES. NO PATIENT INJURIES WERE REPORTED. FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE SITE AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND TO BE OPERATING AS INTENDED WITHIN SPECIFICATION. TO RESOLVE THE CUSTOMER'S REPORTED ISSUE, FSE REPLACED THE FOOT PEDAL. DUE TO THE SITE REPORTING UNINTENDED DISCHARGES OF LASER ENERGY, THIS EVENT IS AN ARO (ACCIDENTAL RADIATION OCCURRENCE) AND THEREFORE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840921 ↗
• InjuryJul 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE THE 14TH, 2024, EL. EN. ELECTRONIC ENGINEERING SPA RECEIVED A COMMUNICATION FROM THE US IMPORTER CYNOSURE OF AN ADVERSE EVENT FOLLOWING A TREATMENT WITH THE DEVICE ELITE IQ. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ LASER MEDICAL DEVICE (REF:(B)(4) , S/N: (B)(6) THAT IS MARKETED IN THE US WITH 510(K) NUMBER K193426 IN THE ABOVE-MENTIONED COMMUNICATION IS REPORTED THE FOLLOWING: CYNOSURE REPORTED THAT THE PATIENT HAS BEEN TREATED FOR HAIR REMOVAL ON THE FACE, SPECIFICALLY ON THE UPPER SIDE OF THE LIP. THE PROVIDER OF THE TREATMENT STATED THAT THE PATIENT MOVED UNEXPECTEDLY DURING THE TREATMENT CAUSING SOME PULSES TO BEING SHOTE ON THE INSIDE OF THE VERMILLION BORDER. THE PATIENT FELT PAIN AND AFTER THE TREATMENT DEVELOPED EDEMA AND BLISTERS ON THE UPPER LIP. DUE TO THE OUTCOME OF THE TREATMENT THE PATIENT SEEKS MEDICAL ATTENTION AT ER AND RECEIVED AN INJECTION (NOT BETTER SPECIFIED). THE PARAMETERS USED FOR THE TREATMENT WERE THE FOLLOWING: 10MM HANDPIECE, ND:YAG LASER SOURCE, 40J/CM2 FLUENCE, PULSE DURATION SHORTER THAN 20MS. PICTURES OF PATIENT'S LESION HAS BEEN ALSO SHARED. THE EVENT TOOK PLACE IN DATE JUNE THE 1ST, 2024 AT DR. (B)(6) CLINIC PLACED IN (B)(6)

  Patient problems: Blister; Pain; Swelling/ Edema

  MAUDE report 19675052 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN, PRONOUNCED EDEMA, AND BLISTERS ON THE UPPER LIP FOLLOWING A LASER HAIR REDUCTION TREATMENT USING ELITE IQ. PATIENT MOVED AND LASER WAS PULSED INSIDE THE VERMILLION BORDER. PATIENT WAS GIVEN 1% HYDROCORTISONE AND FUCIDIN AS PREVENTATIVE MEDICATION. PATIENT WAS ALSO PRESCRIBED ORAL STEROID, BUT DID NOT TAKE THE MEDICATION. PATIENT REPORTED VISITING THE EMERGENCY ROOM AND RECEIVING AN ANTI-INFLAMMATORY INJECTION. TREATMENT SETTINGS USED WERE WITHIN GUIDELINES, ALTHOUGH AGGRESSIVE. CYNOSURE MEDICAL DIRECTOR REVIEWED THE INCIDENT AND ADVISE ORAL STEROID AND A FOLLOW UP WITH A DERMATOLOGIST OR PLASTIC SURGEON. SITE CONFIRMS PATIENT IS ALMOST HEALED DURING A FOLLOW UP VISIT ON (B)(6) 2024. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATING AS INTENDED WITHIN SPECIFICATION. PAIN, EDEMA, AND BLISTER ARE EXPECTED SIDE EFFECTS FROM LASER TREATMENTS, HOWEVER THIS EVENT IS REPORTABLE DUE TO MEDICAL INTERVENTION.

  Patient problems: Blister; Pain; Swelling/ Edema

  MAUDE report 19643406 ↗
• MalfunctionJun 18, 2024Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  ON MAY THE 23RD, 2024, EL. EN. ELECTRONIC ENGINEERING SPA RECEIVED A COMMUNICATION FROM THE US IMPORTER CYNOSURE OF AN EVENT IN WHICH THE DEVICE ELITE IQ EMITTED RANDOMLY WITHOUT THE PRESSURE OF THE FINGER-SWITCH NOR THE PEDAL. THE CUSTOMER COMPLAINTS ABOUT AN EMISSION THAT OCCURRED WITHOUT THE OPERATOR TOUCHING THE HANDPIECE OR PRESSING THE PEDAL. THE PRACTITIONER PROCEEDED WITH THE SHUT-DOWN AND RESTART OF THE DEVICE THAT, ONCE RESTARTED, SHOWED AN ALARM IN WHICH IT WAS REQUIRED TO RELEASE THE PRESSURE FROM THE SWITCH. THE CLINIC REPORTED THAT THE SWITCH WAS DEPRESSED. IN THE COMMUNICATION IT IS REPORTED THAT NO PATIENT NOR OPERATOR HAS BEEN INVOLVED IN THE EVENT. THE PRESENT EVENT HAS BEEN EVALUATED AS A REPORTABLE DUE TO THE FACT THAT THE EVENT REPORESNE AN ACCIDENTAL RADIATION OCCURRENCE (ARO). MOREOVER, THE US IMPORTER, CYNOSURE, PROCEEDED TO SUBMIT THEIR OWN MDR REPORT CODE MDR1222993-2024-00028 IN DATE MAY THE 24TH, 2024. WE THE MANUFACTURER OF THE DEVICE PROCEEDED TO SUBMIT OUR OWN MDR REPORT, IN ACCORDANCE WITH 21 CFR PART 803.50(2) IN ORDER TO SUPPLY ANY MISSING INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556510 ↗
• MalfunctionJun 3, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON MAY THE 8TH, 2024, EL. EN. ELECTRONIC ENGINEERING SPA RECEIVED A COMMUNICATION FROM THE US IMPORTER (B)(6) OF AN OF AN EVENT IN WHICH THE DEVICE ELITE IQ DOUBLE PULSED JUST BEFORE SHOWING A LOW-POWER ALARM. IN THE ABOVE-MENTIONED COMMUNICATION IS REPORTED THE FOLLOWING: THE CUSTOMER COMPLAINT OF TWO FAULTS OCCURRING RELATIVE TO LOW-ENERGY ALARM AND STARTING TO DOUBLE-PULSE. ANYWAY, THE CUSTOMER REPORTED TO HAVE BEEN ABLE TO BYPASS THIS ISSUE SIMPLY BY RE-STARTING THE DEVICE. IN THE COMMUNICATION IT IS REPORTED THAT NO PATIENT NOR OPERATOR HAS BEEN INVOLVED IN THE EVENT. THE PRESENT EVENT HAS BEEN EVALUATED AS A REPORTABLE DUE TO THE FACT THAT THE EVENT REPRESENT AN ACCIDENTAL RADIATION OCCURRENCE (ARO). MOREOVER, THE US IMPORTER, (B)(6), PROCEEDED TO SUBMIT THEIR OWN MDR REPORT CODE MDR 1222993-2024-00019 IN DATE APRIL THE 26TH, 2024. WE THE MANUFACTURER OF THE DEVICE PROCEEDED TO SUBMIT OUR OWN MDR REPORT, IN ACCORDANCE WITH 21 CFR PART 803.50(2) IN ORDER TO SUPPLY ANY MISSING INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447396 ↗
• MalfunctionMay 24, 2024Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED BY THE CUSTOMER SITE THAT THE ELITE IQ WAS FIRING WITHOUT OPERATOR TOUCHING THE HANDPIECE OR PRESSING ON THE FOOTPEDAL. NO PATIENT INJURY WAS REPORTED. FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE SITE AND RESTARTED THE DEVICE. THE DEVICE RESTARTED AND RELAYED A MESSAGE FOR THE OPERATOR TO RELEASE THE FOOT PEDAL. THE OPERATOR WAS NOT TOUCHING THE FOOT PEDAL, BUT MESSAGE STILL APPEARED. TO RESOLVE THE ISSUE, FSE REPLACED THE ELECTRICAL FIBER CABLE. DUE TO THE SITE REPORTING UNINTENDED DISCHARGES OF LASER ENERGY, THIS EVENT IS AN ARO (ACCIDENTAL RADIATION OCCURRENCE) AND THEREFORE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391758 ↗
• InjuryApr 26, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED SCABBING AND ULCERS ON THE LEGS 2 WEEKS POST SPIDER VEIN REMOVAL TREATMENT USING ELITE IQ. CYNOSURE'S CLINICAL TEAM INVESTIGATED THE EVENT AND CONFIRMED USER ERROR WAS INVOLVED. OPERATOR DID NOT PERFORM PATCH TEST PRIOR TO TREATMENT. LABELING INSTRUCTS TO ALWAYS PERFORM PATCH TEST PRIOR TO ANY TREATMENT. THE SMARTCOOL DEVICE WAS ALSO USED ONLY BEFORE AND AFTER TREATMENT, BUT NOT DURING TREATMENT. PER CLINICAL: THIS IS A MAJOR CONTRIBUTION TO THE SIDE EFFECTS REPORTED. THE BURNED LESIONS ON THE SKIN SUGGEST THAT THE WRONG TECHNIQUE WAS USED. INSTEAD OF USING THE SPIDER VEINS TECHNIQUE, THE OPERATOR USED THE LASER HAIR REMOVAL TECHNIQUE. CYNOSURE MEDICAL DIRECTOR OBSERVED FIRST, SECOND AND THIRD DEGREE BURNS AND EXPECTS SOME PERMANENT SCARRING IN AREAS OF FULL THICKNESS TISSUE LOSS. PER CYNOSURE MEDICAL DIRECTOR: PATIENT WILL MOST LIKELY EXPERIENCE SURGICAL DEBRIDEMENT AND/OR PERMANENT SCARRING. PATIENT WAS SEEN BY A BURN NURSE SPECIALIST ON (B)(6) 2024 AND WAS GIVEN NEOSPORIN, SILICONE OINTMENT, AND CIPROFLOXACINE PILLS AS PREVENTATIVE MEDICATION. COMPLIMENTARY VIRTUAL TRAINING WAS DISPATCHED TO THE SITE. BURNS ARE EXPECTED SIDE EFFECTS FROM

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 19190834 ↗
• InjuryJun 27, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON JUNE THE 5TH 2023, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US IMPORTER, CYNOSURE, IN WHICH IT IS STATED THAT A PATIENT DEVELOPED BLISTERS AND BURNS FOLLOWING A VASCULAR TREATMENT PERFORMED WITH THE ELITE IQ LASER MEDICAL DEVICE. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ LASER MEDICAL DEVICE REF: M122B1, S/N: (B)(6), UDI: (B)(4). THE ACTUAL DEVICE INVOVLED IN THE EVENT IS MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE US WITH 510(K) K193426. BASED ON THE NARRATIVE PROVIDED BY THE US IMPORTER, CYNOSURE, IT IS REPORTED THAT A FEMALE PATIENT REPORTED TO HAVE GOT BLISTERS FOLLOWING A TREATMENT, ON THE LOWER LEG, PERFORMED WITH THE DEVICE ELITE IQ FOR SPIDER VEINS (VASCULAR TREATMENT). BASED ON THE PICTURES MADE AVAILABLE OF THE PATIENT'S LESION, IT IS POSSIBLE TO SEE THAT THE BLISTERS HAVE DEVELOPED TO WOUNDS THAT COULD POSSIBLY EVOLVE IN PERMANENT SCARRING. THE ACTUAL DEVICE INVOLVED IN THIS EVENT HAS BEEN EVALUATED IN DATE (B)(6) 2023 IN WHICH THE DEVICE HAS BEEN FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON JUNE THE 5TH 2023 BY SPECIFI

  Patient problems: Blister

  MAUDE report 17207948 ↗
• InjuryJun 8, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED BLISTERS ON THE LEGS FOLLOWING A TREATMENT USING ELITE IQ. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATING AS INTENDED WITHIN SPECIFICATION. USER ERROR WAS CONFIRMED DURING CLINICAL EVALUATION. THE SKIN WAS NOT COOLED PRIOR TO TREATMENT AND SITE LIKELY PERFORMED MORE THAN ONE PASS OVER THE TREATED AREA. LABELING ADVISES: ADVERSE EFFECTS MAY BE REDUCED BY COOLING THE AREA TO BE TREATED PRIOR TO TREATMENT AND REMOVING ALL MAKEUP, LOTIONS OR CREAMS FROM THAT AREA. PATIENT WAS GIVEN PEROXIDE AND POLYSPRINE AS PREVENTATIVE MEDICATION. BLISTERS ARE EXPECTED SIDE EFFECTS FROM LASER TREATMENTS, HOWEVER PERMANENT SCARRING IS A LIKELY OUTCOME AND THEREFORE REPORTABLE.

  Patient problems: Blister

  MAUDE report 17084638 ↗
• MalfunctionJul 20, 2022Radiation Output Problem; Radiation Output Problem

  ON JUNE THE 30TH 2022, EL. EN. ELECRTONIC ENGINEERING SPA BECAME AWARE OF A MALFUNCTION, REPORTED BY THE US IMPORTER, CYNOSURE, IN WHICH IT IS STATED THAT AN ELITE IQ LASER MEDICAL DEVICE WAS FOUND EMITTING LOWER THAN THE 20% FROM THE NOMINAL VALUE SET ON THE DEVICE. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ LASER MEDICAL DEVICE REF: M122B1 S/N: (B)(4) UDI: )B)(4). THE ACTUAL DEVICE INVOVLED IN THE EVENT IS MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE US WITH 510(K) K193426. BASED ON THE NARRATIVE PROVIDED BY THE US IMPORTER, CYNOSURE, THE SERVICE WAS CALLED DUE TO THE FACT THAT THE PATIENT FELT THE TREATMENT TO BE MORE UNCOMFORTABLE, DESPITE WITHOUT ANY IMPACT SUCH AS BURNS. THE CLINIC REPORTED TO THE US IMPORTER THAT PATIENT FELT MORE DISCOMFORT AND MORE HEAT SINCE PREVIOUS TREATMENTS BUT MANAGED THE TREATMENT WITHOUT ANY COMPLICATIONS. THE SITE WAS INSTRUCTED BY THE US IMPORTER TO USE THE COOLER AT OPTIMAL LEVELS TO ASSIST IN PATIENT COMFORT. THE ACTUAL DEVICE INVOLVED IN THIS EVENT HAS BEEN INITIALLY EVALUATED IN DATE 21/06/2022 IN WHICH THE DEVICE HAS BEEN FOUND TO EMIT BELOW THE 20% OF TOLERANCE WITH THE ALEX LASER SOURCE. NO INJURY TO PA

  Patient problems: Pain

  MAUDE report 15066960 ↗
• MalfunctionJul 19, 2022Radiation Output Problem; Radiation Output Problem

  IT WAS REPORTED THAT THE POWER FROM THE LASER ENERGY WAS PAINFUL WHILE USING ELITE IQ. SITE CONFIRMED NO PATIENT INJURY OCCURRED. TECHNICIAN FOUND THE HANDPIECE DELIVERING LOW ENERGY >20% OUT OF SPECIFICATION. DUE TO THE ENERGY OPERATING OUT OF THE SPECIFICATION RANGE, THIS EVENT IS AN ARO (ACCIDENTAL RADIATION OCCURRENCE) AND THEREFORE REPORTABLE.

  Patient problems: Pain

  MAUDE report 15052736 ↗