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)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 2/13/25: sciton clinician received a voicemail from clinic owner.The voicemail stated that she had recently had a two-day preceptorship with a trainer not affiliated with sciton covering bbl heroic/ moxi on bbl (b)(6) 2025 at her practice.Clinic owner stated that she had concerns with the bbl treatment results.Clinic owner stated that one of her patients reported burns and blisters on her face from a bbl heroic procedure.Sciton clinician received this voicemail after hours and was going to be out of the office the following day, therefore, she sent the voicemail to sciton clinical specialist requesting to reach out to the customer directly the following morning.The clinic owner recommended patient to utilize aquaphor.Clinic owner did not prescribe an rx for the patient, however, the clinic owner stated that the patient went to a dermatologist and was prescribed an antibiotic and she is unaware of what antibiotic was prescribed.The clinic owner mailed the patient skin care products including alastin skin nectar and recovery balm.
Additional Manufacturer Narrative
On 2/14/25: sciton clinician specialist reached out to clinic owner on her cellphone (4 times).Sciton clinical specialist stated that the number had a message stating to try again later, however, no voicemail was set up.On 2/17/25: sciton clinical specialist again called the clinic owner.No answer.On 2/21/25: sciton clinical specialist called the clinic owner again.Sciton clinical specialist discussed appropriate safe start parameters in-depth and emailed the heroic reference sheet to the provider.Phone call duration was 16 minutes.On 2/21/25: sciton clinical specialist emailed the provider asking for settings/ pictures/ rx prescribed.On 2/28/25: clinic owner responded to the email and provided patient notes, along with follow up pictures.The clinic owner stated that videos were taken during the training for rosacea treatment.The patient shared pictures of severe unilateral swelling with blistering scattered throughout her left face.The clinic owner asked the non-sciton-affiliated trainer about the settings on this patient and noted that the settings verbally provided by the trainer were completely different than what was on the recorded training video.The clinic owner stated that the following parameters were utilized after watching the video in its entirety: 590st, 20j, 20msec, 10% overlap test sites x5 at left pre-auricular space, then turned overlap to 20%.Then it dropped down to 15j, 15msec, 20% overlap for last half of this pass.Then 2 additional passes: 560 filter 15j, 15msec, 20% overlap.Then 515 pass at 15j, 15msec, 20% overlap.Then, 532+ corrective spots with a 7mm spot size at 8j, 15ms, and 20°c.The clinic owner stated that the patient ended up going to dermatologist and was prescribed an antibiotic, however, she is unaware of what type of antibiotic was prescribed.The clinic owner had the patient scheduled for a follow up on (b)(6) 2025, however, the patient rescheduled.The clinic owner mailed the patient skin care products including alastin skin nectar and recovery balm.The patient is scheduled for a follow up on (b)(6) 2025.On 2/29/25: sciton clinical specialist followed up by email, thanking her for her documentation and stated that if she needed any additional assistance, she can contact sciton directly.On 3/7/25: sciton clinician noted that the incident occurred during a 2 day preceptorship with trainer not affiliated with sciton, therefore, the clinician believes that the above settings do not represent sciton's safe start parameters.The treatment settings applied by the trainer were higher than the safe start parameters which are recommended by sciton in the user manual.On 3/7/25: sciton clinical specialist reached out to the clinic to inquire about patient's condition and left a message.On 3/10/25: sciton called the clinic inquiring about patient's condition and left a voice message to return the call.

• 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: 21576530
• Report Number: 2953696-2025-00042
• Device Sequence Number: 8340929
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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: 52924
• 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: 02/13/2025
• Initial Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female