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	Partial thickness (Second Degree) Burn (2694); Blister (4537); Hypopigmentation (4838)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) 26: sciton clinical received an email from a customer asking for clinical guidance on how to proceed treating a patient who is being treated with bbl and received a burn (minor blister) from a previous bbl procedure performed in (b)(6) 2025.Patient was using skin nectar by elastin.The patient's skin has healed and is now experiencing areas of hypopigmentation.
Additional Manufacturer Narrative
5/7/26: clinic provider emailed sciton clinical stating that she had maxed out her treatment settings for the patient as a fitzpatrick 2 and wanted to know if the next step was to skin type the patient as a fitzpatrick 1.Sciton clinical responded to the email and stated that while skin typing patients it is always safer to skin type up, therefore, recommendations would be to skin type the patient as a fitzpatrick 3.Along with providing this information, sciton clinical asked the provider to provide the treatment parameters and photos of the patient from the time of the incident.Sciton clinical reiterated to the provider that it would be important for the patient to keep the skin clean, moist with an occlusive, and avoiding all sun exposure.5/19/26: sciton clinical received a voicemail from clinic provider stating that she emailed the clinical team and has not received a response back.5/20/26: sciton clinical called the clinic provider to discuss the patient case.Sciton clinical asked the provider which email id she had sent the clinical information to and she provided an inaccurate email address.Sciton clinical told her that the sciton's clinical department email address is clined@sciton.Com.During the phone conversation, provider stated that she has been treating a patient who received an adverse event which subsequently caused striping on the patient's upper left forearm.She stated that this was done by another provider at the office, however, the patient is now under her direct care.Prior to moving forward with the conversation, sciton clinical stated that it would be very helpful and beneficial to speak with the other provider as well to discuss the case and proper precautions moving forward.Provider agreed with this plan.Clinic provider stated that the procedure was performed on 10/13/25.After treating the upper left forearm, the patient's skin turned red and started to become painful.After the treatment, the patient was instructed to apply alastin skin nectar, aquaphor, and was prescribed a medrol dosepak.Clinic provider stated that since then she has been working with the patient using bbl to help blend the upper forearm.She provided settings and pictures to show the progression through email.Forty five minutes were spent on the phone discussing the patient in depth.Clinic provider provided the treatment parameters through email but it was noted that they did not follow the treatment parameters and protocols provided by sciton.The provider believed that the machine auto-populated to safe start parameters and she believed that the body protocol entailed a base pass followed by 2 additional passes.Sciton clinical reiterated that bbl hero does not auto-populate to safe start parameters and that all settings must be manually entered by utilizing the sciton's protocol.When talking with clinic provider on the phone, she stated that she has been performing bbl treatments every 2-3 weeks.Sciton clinical reiterated that bbl treatments should be spaced out atleast every 4 weeks apart, as body tissue does not heal like facial skin.Provider wanted to see what my recommendations would be for treatment moving forward.Sciton clinical explained that repigmentation will occur and that time will be key.Also, discussed that lightening agents could be utilized to help blend the area.Discussed that with the summer months ahead, one will have to be more cautious performing bbl, however, we would be happy to send the photos off to a sciton's kol to gather insight on how they would proceed with treating this patient.Prior to ending the call, sciton clinical told clinic provider that we would be happy to send this off to a sciton kol, however, we would need a thorough timeline written including treatment parameters and photos as the previous email was lacking sufficient information.Clinic provider stated that she would compile this information and then send me an email back.After finishing the phone call, sciton clinical sent the bbl hero protocol to the provider.5/21/26: clinic provider emailed back providing photos and treatment parameters of the patient.Clinic provider stated that it would be helpful to set up a phone call with the other technician who caused the adverse reaction.Sciton clinical told clinic provider that we would be happy to jump on a phone call with both of them to discuss the case and protocols in more depth.Sciton clinical responded stating that the patient appear tan and to be a darker fitzpatrick skin type.Sciton clinical stated that the initial settings utilized were not indicative of bbl hero.Sciton clinical reiterated hero protocol and the recommendations that treatment should take place every 4 weeks apart.Discussed various clinical learning resources available on linq along with the sciton website.After completing the phone call, sciton clinical sent an email to sciton's kol asking for clinical insight into this patient case.Treatment parameters provided: ((b)(6) 26) filter skin type 2 fluence pulse rate chill shots.560 base left upper arm 10 j/cm2 6 ms 1.0 hz 25°c 235.515 pigment left upper arm 14 j/cm2 15 ms x 20°c 45.((b)(6) 26) filter skin type 3.560 base left upper arm 5.5 j/cm2 3 ms 1.0 hz 25°c 250.515 pigment left upper arm 10 j/cm2 15 ms x 18°c 46.5/26/26: sciton clinical received an email back from clinic provider with the additional information, however, there was not enough information regarding the initial treatment parameters utilized, therefore, further clarification was needed.Emailed provider for more details.5/26/26: clinic provider responded to the email with the initial treatment parameters details.Clinic provider did not respond to sciton clinical statement regarding setting up a follow up clinical phone call.Settings from 10/13/25: filter skin type 2 560 base left upper arm 5 j/cm2 3 ms 1.0 hz 25°c 4 passes total with bbl forever young +.515 pigment left upper arm 7 j/cm2 20 ms 1.0 hz 18°c 1 pass total with bbl forever young.Sciton clinician's assessment: there are various factors that may have contributed to this adverse event including sun exposure, inappropriate skin typing, and inappropriate treatment parameters utilized.

• 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: 25385622
• Report Number: 2953696-2026-00060
• Device Sequence Number: 10450089
• Product Code: GEX
• UDI-Device Identifier: 00863249000329
• UDI-Public: 0863249000329
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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 Lot Number: 51653
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/03/2026
• Date Device Manufactured: 07/31/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female