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	Blister (4537)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On may 18, 2024, it was reported by the clinic staff to sciton clinical specialist that the patient was treated with an overlap of about 50%, which may have caused a blister during hair removal treatment of very thick beard.It was also reported that the patient did not receive any cooling or prophylactic steroid application after the treatment, and the aftercare was insufficient.The sciton clinical specialist re-iterated the proper treatment techniques and parameters to the clinic and provided advanced training to the physicians on may 7, 2024.
Event or Problem Description
Patient information: sex: male, age: 40's, nationality: japanese, skin type: iv, first time beard removal (no prior cosmetic procedures), treatment area: philtrum, mode: forever bare.Treatment details: the nurse performed the treatment under doctor's direction.It was reported that on (b)(6) 2024, the patient, a first-time facial hair removal client with no prior cosmetic treatment experience, underwent the facial hair removal procedure.Although the patient's facial hair was thoroughly shaved, it remained quite dense.The following settings were used: mode: static, skin type: iv, hair color: black, hair thickness: coarsest, hair density: highest, adapter: 15×15, filter: 640nm (as recommended on-screen), energy: 12 j/cm², pulse duration: 25 msec, temperature: 10 degrees, passes: 1, overlap: approximately 50%, the patient experienced pain during the procedure, but had no immediate post-treatment skin problems.Post-treatment follow-up: three days post-treatment, the patient reported blistering in one area of the philtrum.Betamethasone valerate was initiated, and the blister has since disappeared and is 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: 19515490
• Report Number: 2953696-2024-00037
• Device Sequence Number: 15273620
• Product Code: GEX
• UDI-Device Identifier: 00863249000329
• UDI-Public: 0863249000329
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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: MJOULE
• Device Catalogue Number: 1500-020-71
• Device Lot Number: 52067
• 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: 05/17/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2023
• 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 Sex: Male
• Patient Race: Asian