MAUDE Adverse Event Report: SCITON INC. JOULE WITH CLEARV HANDPIECE, VASCULAR; POWERED LASER SURGICAL INSTRUMENT

Model Number	JOULE
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, it was reported that a patient treated with clear v for port wine stain experienced an adverse event.
Additional Manufacturer Narrative
On (b)(6) 2023 received text message regarding a patient treated with clear v for a port wine stain and a photo showing an adverse event had occurred.Sciton immediately reached out to the office manager at caps who did not have treatment settings available at the time of our call but would email the settings later.Md has already put the patient on keflex and silvadene to be applied to the wound.She has also ordered the patient for hyperbaric oxygen treatments.Sciton clinical nurse advised to keep the area well occluded and protected.Once the treatment records are received, sciton informed caps to discuss the prevention in the future.Caps nurse practitioner sent the treatment records the evening of (b)(6) 2023 and sciton clinical nurse sent them to two sciton preceptor mds for recommendations.Recommendations were given to the customer to keep area clean and protected, and would likely need some additional treatments for any defect once healed.The cause of the adverse event was deemed improper settings selected by the provider.Caps nurse practitioner thanked sciton for the response and asked if we could get on a call with the providers the week of (b)(6) 2023.Updated photo of the patient on (b)(6) 2023 showed that the wound had greatly improved, no necrosis and pink granular tissue as well.On (b)(6) 2023, sciton learned that the patient delayed going in for hyperbaric oxygen treatments till the week of (b)(6) 2023 because she was at the beach all weekend.On (b)(6) 2023 sciton service engineer inspected the system, and no device related issues were found.On (b)(6) 2023, caps reported to sciton clinical nurse that the patient is doing well and improving every day.They have discontinued the keflex and silvadene, the patient is now only applying aquaphor and keeping the area covered for protection.Sciton clinical nurse also discussed treatment techniques to help eliminate potential adverse reactions in the future.

• Brand Name: JOULE WITH CLEARV HANDPIECE, VASCULAR
• 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: 17390502
• Report Number: 2953696-2023-00030
• Device Sequence Number: 8885088
• Product Code: GEX
• UDI-Device Identifier: 00863249000305
• UDI-Public: 0863249000305
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 07/25/2023

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: 1500-302-00
• Device Lot Number: 18005
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female