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 Codes	Blister (4537); Swelling/ Edema (4577)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2025: an email was sent by clinic physician reporting that she had performed a bbl on a fitzpatrick 1/2 for rosacea.Clinic physician stated that she had utilized protocol outside of sciton recommendation in the user manual since the patient did not respond to her previous treatment where she utilized the 560 filter followed by a vascular correction pass only.Clinic physician stated that the patient experienced severe edema and blisters.Clinic physician stated that the blisters were limited to the right cheek and occurred the following morning.Clinic physician stated that the patient was prescribed prednisone, doxycyline, and valtrex to prevent infection.Also, the patient was utilizing vaseline for wound care.The following treatment parameters were provided by the clinic physician: indication: rosacea, telangiectasia, and photodamage location: cheeks bbl 515m filter module with 15 x 45 mm (no finesse adapter) spot size was used fluence: 7 j/cm2 pulse duration: 3 milliseconds total pulses: 100 per cheek repetition rate: 3 hz cooling was performed at 25 degrees celsius treated area size: small area passes: 1.Indication: rosacea, telangiectasia, and photodamage location: forehead, nose, perioral, and chin bbl 515m filter module with 15 x 15 mm square spot size was used fluence: 7 j/cm2.Pulse duration: 3 milliseconds.Total pulses: 150 (forehead), 100 (perioral), 50 (nose) cooling was performed at 25 degrees celsius.Passes: 1 indication: rosacea and telangiectasia location: nose, cheeks, and chin bbl 560m filter module with 11 mm round spot size was used fluence: 17 j/cm2.Pulse duration: 15 milliseconds cooling was performed at 20 degrees celsius.Passes: 1 indication: rosacea and photodamage location: cheeks bbl 560nm filter module with 15 x 45 mm (no finesse adapter) spot size was used fluence: 5 j/cm2 pulse duration: 3 milliseconds total pulses: 80 per cheek cooling was performed at 25 degrees celsius.Passes: 1 on (b)(6) 2025: sciton clinical spoke with clinic physician on the phone and discussed that the protocol utilized is different than the safe start protocol provided by sciton.Clinic physician was aware that the protocol is not considered sciton safe start protocol.Sciton clinical discussed that the number of pulses delivered to the face are lower within sciton's protocol.Also, discussed that recommendations are to utilize the 15x15mm adapter rather than the 11mm when treating for rosacea.Clinic physician stated that she had utilized the 15x15mm adapter on the previous visit but had not seen any results, therefore, she utilized the protocol which was not recommended in sciton user manual.In closing, sciton clinical discussed the possibility that the patient may present as a darker fitzpatrick skin type.Sciton clinical discussed that recommendations would be to keep the skin clean, moist with an occlusive such as aquaphor, and avoiding all sun exposure.After the call, sciton clinical sent the sciton fybbl+ protocol, along with a fybbl+ reference guide sheet to the clinic physician.On (b)(6) 2025: sciton clinical reached out to clinic physician through email to check in on the patient's recovery.On (b)(6) 2025: clinic physician responded to the email and stated that the patient is continuing to heal well, however, she is worried about the residual reddness.Updated photos were provided.On (b)(6) 2025: sciton clinical responded to clinic physician email stating that the patient appears to be healing well.Discussed the importance of continuing wound care measures, along with avoiding sun exposure and wearing sunscreen.Also, stated that the reddness will continue to subside over the next coming weeks.Sciton clinician's assessment: the cause of this adverse reaction could be due to various reasons including treatment parameters and inaccurate skin typing.
Event or Problem Description
On (b)(6) 2025: sciton clinical received an email from clinic physician reporting that an adverse outcome had occurred while performing a bbl on a patient who came in for a rosacea treatment.Clinic physician stated that the sciton sales representative advised her to email sciton clinical department to provide further guidance.

• 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: 24254542
• Report Number: 2953696-2026-00056
• Device Sequence Number: 8327172
• Product Code: GEX
• UDI-Device Identifier: 00863249000305
• UDI-Public: 0863249000305
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: JOULE
• Device Catalogue Number: 1500-004-50
• Device Lot Number: 18302
• 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: 01/07/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female