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

Model Number	MJOULE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 08/12/2024: owner of the clinic contacted sciton representative reporting that the patient's chest had burn following mjoule bbl heroic training on (b)(6) 2024 with 515 nm filter.The patient is a staff member (nurse practitioner) with allegedly some immunocompromised issues with her health.
Additional Manufacturer Narrative
On 08/13/2024: sciton clinicial rn reviewed the images and suspects a couple of blisters.Sciton clinical rn was informed by the clinic that the patient has been prescribed clobetasol, and silvadene medications.On 08/16/2024: the system was checked by sciton service to investigate why the machine would not start at safe start protocol as reported by the sciton clinical trainer.The system was turned on and off multiple times during service visit to try and duplicate the reported issue at fluence 5 j/cm2 and 3ms pulse width with the 515 filter in user mode.The service engineer could not duplicate the issue.Device was inspected and no device issues were found during the inspection.On 09/09/2024: sction contacted the clinic and was informed that the patient is recovering and healing well.

• Brand Name: MJOULE
• 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: 20185367
• Report Number: 2953696-2024-00038
• Device Sequence Number: 8722670
• Product Code: GEX
• UDI-Device Identifier: 00863249000329
• UDI-Public: 0863249000329
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/09/2024

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
• Device Model Number: MJOULE
• Device Catalogue Number: 1500-020-70
• Device Lot Number: 52508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/10/2024
• Date Device Manufactured: 07/26/2024
• 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