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

Model Number	JOULE
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Blister (4537)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) 2026: after the call with the patient on (b)(6) 2026, sciton service sent an email to the patient requesting details of the event and included the sciton clinical team in cc.(b)(6) 2026: patient sent following email to sciton service and sciton clinical."to whom it may concern, i am reaching out to share my experience following a treatment involving a sciton bbl laser, in the hopes of receiving guidance and gaining insight from your team.I want to be clear that i understand sciton was not personally involved in my care, but that i truly appreciate you guys taking the time to review my case.On (b)(6) 2024, i received a bbl treatment on my face done by clinic nurse practioner.For context, i have undergone aesthetic treatments for years and am very familiar with proper pre- and post-care protocols avoiding actives, sun exposure, ensuring clean skin, etc.).Immediately following the procedure, i developed a significant blister on my chin.I was advised to apply a cool compress as well as to take benadryl.Over the following days, the blister worsened and ultimately became infected, at which point mupirocin ointment was prescribed.Less than a week later, on (b)(6) 2025, i was asked to return to the office (under the radar might i add - this was not charted in my medical records that i've since requested).During that visit, the dried scab was picked and removed, which resulted in a very deep wound on my chin.I was instructed to continue applying mupirocin twice daily and was reassured that the area would heal without scarring.Over the next several weeks, i allowed time for healing and took immense care of the wound while doing so.However, by (b)(6) 2025, it became clear the area developed into a hypertrophic scar.Over the following months, i underwent a series of interventions at the same treating clinic (all at their recommendation), including: · intralesional kenalog injections (beginning (b)(6) 2025- (b)(6) 2025, and every 4-6 weeks or so thereafter post laser resurfacing treatment referenced below).· sciton's clearsilk laser ((b)(6), 2025 - for the redness of scar but such a pointless treatment for this particular case).· microneedling ((b)(6), 2025), which resulted in the scar getting angrier and exacerbating the already present inflammation.· laser resurfacing ((b)(6) 2025).Despite continued treatment for nearly an entire year, there was little improvement up to that point.At no point during this period was responsibility clearly acknowledged by the clinic for even the initial mistake that they caused.Just consistent blame on me and my skin and the reasons i could have caused this.In (b)(6) 2025, i requested the clinic dr himself to take over my care.While initially reassured (just as i was over the last year), i was later informed in (b)(6) 2026 (after dr.Did, yet another, intralesional kenalog injection into the scar - his one attempt with me under his care) that the scar was permanent and that there were essentially no more corrective options available.Since that time, i have explored corrective options elsewhere from various providers, including two other dermatologists as well as a plastic surgeon, and have also incurred personal expenses in attempting to correct this outcome.I've been encouraged to contact sciton directly by these well-respected providers, as well as by mf, as your team may be able to provide valuable perspective and even explore any potential path forward.Given the ongoing nature of this issue, i would greatly appreciate the opportunity to be connected with the appropriate clinical liaison on your team.I am happy to provide supporting documentation, including photographs, treatments timelines and medical records upon request.You may email me directly or call me on my personal phone anytime.Thank you so much for your time and attention to this matter." (b)(6) 2026: sciton regulatory spoke with the treating nurse practitioner.She stated that the patient was treated using the new handpiece but she did not utilize the safe start settings recommended by sciton for new handpieces.The clinician was informed that it is advised to revert to safe start settings when using a new handpiece, as it may deliver more energy than the previous handpiece.(b)(6) 2026: sciton regulatory sent an email to the treating nurse practitioner asking for device serial number.(b)(6) 2026: no response from np.Sciton regulatory sent another email to the treating np asking for device serial number.(b)(6) 2026: sciton regulatory called the clinic and left message for treating np to confirm the serial number of the device.(b)(6) 2026: sciton regulatory called the patient and informed her that sciton is not licensed to practice medicine and recommended to contact the treating physician to resolve her concerns.
Event or Problem Description
Patient called sction service on (b)(6) 2026 reporting an adverse event from the treatment on (b)(6) 2024.

• Brand Name: JOULE
• 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: 24974419
• Report Number: 2953696-2026-00058
• Device Sequence Number: 4979537
• Product Code: GEX
• UDI-Device Identifier: 00863249000305
• UDI-Public: 0863249000305
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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: JOULE
• Device Catalogue Number: 1500-095-10
• Device Lot Number: 11908
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/23/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female