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	Blister (4537)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
07/23/2024: sciton service sent an email to the sciton clinical education department describing the following events: "clinic np stated that during a power outage at their facility they had experienced an adverse clinical event during a bbl treatment.Service is replacing their handpiece due to an id 714 cold side sensor error.Clinic np noted that she did manage to document the event and had questions about treatment moving forward and how to address the event that occurred." 7/25/24: sciton clinician reached out directly to clinic np after receiving the email from sciton service.7/29/24: sciton clinician received an email from another sciton clinican regarding this account and she inquired if sciton clinician had heard back from clinic np.Sciton clinician stated the she had not hear back from clinic np.Sciton clinician believed she was going to be training them, therefore, sciton clinician asked the other sciton clinician to reach back out to offer assistance as she would be their trainer.9/3/24: sciton clinician received an email from clinic np providing a full summary of the patient.Sciton clinician had not heard back from the customer since she initally reached out.Full email regarding the patient is presented below."for this particular treatment the plan was for an additional stax-however following the bbl it was evident that there was an adverse event and no further treatment was performed on the neck.Immediately post there was only one blister present that was maybe a 2 mm spot and the remainder of the tissue looked slightly dusky (similar to telangiectasia clinical endpoints), however welts were forming.The skin was dressed with puracyn soaked gauze and a zimmer was used to alleviate any discomfort.Following this, exosomes were applied followed by alastin nectar.The patient was provided additional exosomes to apply over the next few hours.The patient was instructed to keep tissue cool by applying cold compresses (no ice), recommended biafine burn cream and to continue the exosomes.The patient was instructed to follow up if additional blisters formed for a prescription of silvadene.(however the patient denied additional blistering until almost 3 days post, and we were unable to reach him via phone).Patient was instructed to apply aquaphor to all zones once it was apparent there were blisters and given a prescription of mupirocin d/t risk of mrsa history and given a prophylactic course of keflex.The patient came into the office where clinic performed a light soak and very minimal debridement of already sloughing eschar at day 5.At this time, it was determined the risk of infection was low and silvadene wasn't necessary.The patient was instructed to continue aquaphor application, to continue exosomes and to apply mupirocin bid and to keep the sites covered with sterile gauze.Patient was also instructed to continue minimum of bid vinegar soaks and instructed to finish his course of keflex.(b)(6) 2024 patient has continued to use plated exosomes at home and keep occlusives on until fully healed.Clinic np saw the pt in the office and patient has minimal fibrous tissue present that could result in long term scar formation, but the primary concern is hypopigmentation.Clinic will be seeing the patient in office next week to do a light bbl hero/heroic.Clinic np is new to heroic so may stick with some bbl and possibly do a little profrac with some steroid dripped over any areas that present as early scar formation.Clinic np do have some concerns about the ability to blend these zones out as the patient had severe pk and redness.Clinic np would love any additional help and a follow up." 9/3/24: after receving this email, sciton clinician left clinic np a voicemail offering clinical assistance, along with asking for pictures of the patient as they were not attached to the email.9/3/24: clinic np texted sciton clinician back and stated that she did not need assistance at this time, however, she had been told to email sciton regarding this event.Clinic np did not send any follow up photos.Sciton clinician told clinic np that she would be happy to discuss things further through email or phone call, however, sciton clinician noted that clinic np did not need assistance at this time.Sciton clinician also reached out to other sciton clinician regarding this account and other sciton clinician stated that she had contacted the customer and left a voicemail, however, she did not hear back from them.9/13/2024: sction called utah facial aesthetics-draper clinic to inquire about the event and left voice message at front desk to call back.9/13/2024: sction received a call back from utah facial aesthetics-draper clinic.The clinic reported that the patient is recovering well and no further assistance is required.Device was checked by the clinic and no issues remain.
Event or Problem Description
The customer contacted sciton service with an id 714 error on bbl handpiece.Customer reported that the power went out in the building and that the patient had an adverse clinical reaction to the treatment.

• 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: 20317326
• Report Number: 2953696-2024-00039
• Device Sequence Number: 7782400
• Product Code: GEX
• UDI-Device Identifier: 00863249000305
• UDI-Public: 0863249000305
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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: 18400
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 09/27/2024
• Date Device Manufactured: 02/19/2021
• 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: Male