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

Model Number	JOULE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 10/16/2023: sciton clinical asked following questions to clinic rn : please provide the serial number.Was this halo treatment provided on the same day of the face lift surgery? also - was the copd and collapsed lung immediately after the surgery? may we send the photos to one of our kol physicians for assistance? 10/16/2023: clinic rn replied to sciton clinical: serial number # (b)(6).It was done immediately after facelift - while patient was still under ga.She has history of copd and collapsed lung - did not happen post op.Yes can send pic to you kol.10/16/2023: sciton clinical forwarded the pictures to a luminary physician for advice.The physician advised - "looks like had simultaneous facelift and cooked the flap.Let it heal.Hyperbaric may help.When healed we can fix with some bbl and profractional." 10/17/2023 sciton clinical emailed clinic asking following questions: when was the combination facelift/halo procedure performed? when were the photos taken? (you said two weeks after - just trying to establish the date).What treatment or cream/ prescription creams have been used up to today? how is the patient doing now? 10/17/2023: clinic rn replied to sciton clinical: correct ! i work with dr (b)(6).Surgery was (b)(6) 2023.Photos were taken 2.5 weeks ago.Currently on ssd cream , doxycycline rx.She is ok but very anxious.10/17/2023: clinic rn later corrected that the pictures were taken on oct 16 (12 days post operation).11/02/2023: sciton regulatory called field service engineer who performed the preventive maintenance on the system on 10/27/2023 to inquire about the condition of the laser head related to halo treatment.The fse report dated 10/27/2023 shows that both 2940 nm and 1470 nm laser heads outputs were within specifications.
Event or Problem Description
An adverse event reported for a patient who had face and neck lift procedure with halo application while the patient was under general anesthesia.

• 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: 18116773
• Report Number: 2953696-2023-00032
• Device Sequence Number: 15338682
• Product Code: GEX
• UDI-Device Identifier: 00863249000305
• UDI-Public: 0863249000305
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/10/2023

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: 1500-057-00
• Device Lot Number: 18472
• 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: 10/16/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2021
• 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