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	Partial thickness (Second Degree) Burn (2694)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sciton rn spoke to clinic rn on phone regarding patient.Patient had received a bbl treatment in (b)(6) 2023 and had no adverse reactions.Settings were: 560 filter 8/10 j, 15 width, 15 temp-2 passes, 560 filter 17/20/20 1 pass, 515 filter 16/15/25 1 pass, 515 filter (spot tx) 15/15/15.On 9/8/23, the patient was treated with bbl hero.Clinic rn categorised patient as skin type 2 and performed bbl hero treatment.Treatment parameters were: 560nm, 6j/cm2, 3ms, 3.5hz, 25°c, (15x45mm), 560nm 8j/cm2, 3ms, 3.5hz, 25°c, (15x15mm), 515nm 16j/cm2, 15ms, 25°c (15x15mm), 515nm 15j/cm2, 15ms, 15°c (7mm).It was reported that the patient received burn after the treatment.Clinic rn stated that the patient was prescribed a topical "steroid" and a topical antibiotic from her private dermatologist.Clinic did not receive the medication names for either topicals.Clinic rn instructed the patient to keep the skin moist with an occlusive such as aquaphor and sent her stratacel for wound "healing".Sciton rn discussed with clinic rn that the patient appeared to be skin type 3 and the treatment settings were inappropriate for this skin type.Sciton rn discussed that the 590nm filter would have been recommended for the primer pass and also, when changing from the full crystal to the square adapter, the clinician does not have to adjust the joules.Also, since clinic rn treated the patient as a skin type 2, the pigmentation settings were too aggressive and not appropriate for her skin type.Sciton rn discussed with the provider to work at a lower hertz rate on the face.Lastly, sciton rn discussed in-depth the skin typing matrix since clinic rn stated that they do not utilize a skin typing matrix in their office.Sciton rn emailed clinic rn a skin typing matrix, along with the joule operator manual to reference the hero protocol.Clinic rn stated that the patient came into the office on (b)(6) 2023 and the skin looked like it was healing well.Clinic rn stated that she told the patient that she would like to reevaluate her in 2 weeks and possibly start her on a topical regimen for pih.
Event or Problem Description
On 09/15/2023, sciton rn received an email from clinic reporting that the patient experienced bbl burns on her face from the procedure with bbl on (b)(6) 2023.

• 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: 17882144
• Report Number: 2953696-2023-00031
• Device Sequence Number: 7418466
• Product Code: GEX
• UDI-Device Identifier: 00863249000305
• UDI-Public: 0863249000305
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2023

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: 18133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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