MAUDE Adverse Event Report: SCITON INC. MJOULE; POWERED LASER SURGICAL INSTRUMENT

Model Number	MJOULE
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Blister (4537); Hypopigmentation (4838)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The sciton associate area sales representative received photos and a report from clinic rn that one of the providers had burned a patient's legs performing forever bare on the mjoule bbl heroic and sent a message to clined@sciton.Com on 09/23/2025 at 10:53 am.The treatment was performed around 1:15 pm on (b)(6) 2025.The treatment resulted in evidence of overtreatment with 2 small blisters and discoloration in the pattern of the 15x45 mm bbl sapphire crystal.
Additional Manufacturer Narrative
On 09/23/2025: sciton clinical specialist reached out to clinic rn via cell phone and left a voicemail to return the call at 11:23 am and clinic rn then returned the call at 3:46 pm.While speaking with clinic rn, she three-way called the provider who performed the treatment.Sciton clinical specialist obtained the details that the patient was treated on (b)(6) 2025 and again on (b)(6) 2025 with one of their "non-heroic" systems sn (b)(6) with forever bare motion without adverse event.The patient stopped treatments over the summer and returned on (b)(6) 2025 and was treated with their bbl heroic forever bare.They did not have the settings at the time of the call but would try to get them to me.During the call the provider had to abruptly end talking as she had to attend to a personal matter.Sciton clinical specialist advised them that i would try to obtain the settings from sciton iq.Clinic rn informed sciton clinical specialist that they treated the burns with the following: puracyn prn for itching and moisture, exosomes on blistered areas 2x per day for 5-7 days, hydrogel and hydrocolloid patches 2-3x per day, silvadene 2x per day.Once skin is clean, dry and intact, apply copper peptide 2x per day.Patient was seen by the office at least twice a week since the event.Clinic rn stated that she would try to have the provider call the sciton clinical specialist another day when she has more time.Sciton clinical specialist followed up our call with a follow up email at 4:44 pm reiterating that she would be available to talk more with the provider the next day 9/24 to review the settings as well as treatment pearls to avoid complications.Following the call, sciton clinical specialist was able to obtain the treatment settings used on (b)(6) 2025 from sciton iq and they were: 14 j/cm2, 18 ms, 10% overlap, 13 degrees, followed by 18 j/cm2, 16 ms, 10%, 15 degrees, 20 j/cm2, 14 ms, 10%, 15 degrees, and 22 j/cm2, 12 ms, 10%, 15 degrees.A total of 503 pulses.After learning the settings, sciton clinical specialist tried to call clinic rn back at 5:07 pm and left a message stressing that user error in adjusting the settings was the cause of the burns and that she wanted to schedule a time to review with the providers adjusting settings to achieve clinical endpoints.Clinic rn emailed back at 10:39 pm but just listed the post adverse events treatments that she has listed already.10/01/2025: when sciton clinical specialist did not hear back from clinic rn, she sent a follow up email on october 1st, 2025 at 4:28 pm asking if there would be a time that she could review with the providers the treatment protocols and settings.She also attached the heroic forever bare protocol from the operators' manual.At 6:37 pm clinic rn replied that she forwarded my message to the office manager, and they were still trying to obtain the settings used.10/02/2025: sciton clinical specialist replied on october 2nd, 2025 at 9:10 am that she had the settings and that she was hoping to review with the providers the treatment protocol and adjusting of settings to achieve clinical endpoints.Clinic rn replied back at 7:35 pm that the only time the providers would be available would-be october 15th at 12:00 pm.10/03/2025: sciton clinical specialist confirmed with clinic rn on october 3rd, 2025 at 6:04 pm that she would send a zoom invite to her for october 15th at 12:00 pm for our review session.10/15/2025: zoom review was held with four clinic aprns.Sciton clinical specialist reviewed with them the importance of always starting with the safe start settings that the system defaults to, based on the selected characteristics of the hair at the time of the visit.Also reviewed the settings that are provided in the operator's manual.It was discussed that if the starting settings are not achieving clinical endpoints to only increase by 1 j, then test again.If there is still no response then increase by another 1 j and test again and if after increasing by a maximum of 2 j, testing every step along the way but clinical endpoint is still not achieved, then they could decrease the pulse width by 3 to 5 ms depending on skin type.It was also discussed that since they have multiple systems, the settings used on one device are not interchangeable with another device and that they should just always start with the safe start settings based on the device they are using for the selected hair characteristics at the time of the visit.Additionally, if they were to replace a handpiece, that it will be stronger and for all protocols they should always start with the safe start settings and adjust only as needed.All clinic rns verbalized an understanding of topics discussed.On 10/15/25, clinic also provided an update that the patient healed well with no evidence of scarring or textural changes from the blistered area.The patient started on a compounded tretinoin, hydroquinone, and topical steroid cream last week.Patient was also seen by a dermatologist who confirmed that although there is some slight hypopigmentation, there is still evidence of the presence of melanocytes.His recommendation was to allow the patient to heal for 6 months before attempting any additional treatments to try to blend the hypopigmentation.The providers verbalized that they would reassess the patient after she has used the compounded topical for 10 to 12 weeks and decide if they will do a light bbl with the 515 filter to attempt to blend any residual pigmentary differences or consider halo or moxi at that time.

• Brand Name: MJOULE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): SCITON INC.; 925 commercial street; palo alto CA 94303
• Manufacturer (Section G): SCITON INC.; 925 commercial street; palo alto CA 94303
• Manufacturer Contact: jay patel ; 925 commercial street; palo alto, CA 94303 ; 6504939155
• MDR Report Key: 23361459
• Report Number: 2953696-2025-00053
• Device Sequence Number: 8786197
• Product Code: GEX
• UDI-Device Identifier: 00863249000329
• UDI-Public: 0863249000329
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MJOULE
• Device Catalogue Number: 1500-020-70
• Device Lot Number: 53025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown