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 Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 2/13/2025: owner of the clinic reached out to sciton's clinical specialist requesting clinical treatment records on a patient.The provider stated that she had burned a patient with bbl heroic on bilateral arms.Patient followed post-care protocols and provided updated photos to the provider.Silvadene topical was applied to arms for several days post-treatment.
Additional Manufacturer Narrative
On 2/13/2025: the clinical treatment parameters were obtained through sciton iq.Settings utilized were skin type i-ii, 532 9j, 15ms, 15°c, 157 pulses, 7mm.The provider started with bases passes and stated that she was not getting results on "default settings", so she switched to spot treatment.She started spot treatment with the 7mm, 532 nm then switched over to the 15x15 mm crystal.The provider stated that she did multiple pulses over areas when she was spot treating.After the treatment, recommended patient to keep the area moist with an occlusive, clean, and avoid all sun exposure.The provider stated that she ordered silvadene for the patient.The provider will re-evaluate area 6 weeks after arms have healed.On 2/14/2025: photo updates provided by provider.On 2/15/2025: photo updates provided by provider.On 2/18/2025: photo updates provided by provider.On 2/21/2025: sciton's clinical specialist talked to the provider on phone and received update on the patient.Sciton's clinical specialist offered a virtual didactic, however, the provider stated she would like one but is busy.Sciton's clinical specialist discussed that the cumulative fluence was high and went over body protocols again over the phone call.On 2/25/2025: photo updates provided were provided by the provider.The provider stated that she had the patient start using is clinical serum.On 3/10/2025: sciton's clinical specialist checked in with the provider.Photo updates were provided.Per photos, there was redness on patient's arms, but it is healing well.The provider stated that the patient is being diligent with post-care.

• 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: 21602290
• Report Number: 2953696-2025-00043
• Device Sequence Number: 11855541
• Product Code: GEX
• UDI-Device Identifier: 00863249000329
• UDI-Public: 0863249000329
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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: 52851
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2024
• 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