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

Model Number	BBLS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Blister (4537); Hyperpigmentation (4837)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On april 19th, 2024, section field service engineer checked the device and reported the following: it was found that the sapphire block on the handpiece (s/n (b)(6) manufactured feb 2018) was loose and pushed in during use by the doctor.Upon inspection of the bbl hp the sapphire block had multiple chips on the interior side.The damage to the sapphire indicates that the handpiece may have been dropped causing the sapphire block to be loose and pushed in.Fse has inspected the system and there are no issues with the system other than the broken handpiece.
Event or Problem Description
On apr 23, 2024, the following information was reported by the clinic to sciton clinical specialist: patient information: age: 50.Nationality: japanese.Skin type: iv.Initial visit (no prior cosmetic procedures).Medical history: past medical history: none.Present illness: none.Treatment was performed on (b)(6) 2024: it was reported that bbl treatment was administered by the physician for rejuvenation purposes, targeting liver spots.590nm, 10j, 20msec, 15°c, 15×45 - full face (large area), 1 pass, 50 shots 640nm, 10j, 20msec, 15°c, 15×45 - liver spots (cheeks, cheekbones), 1 pass, 20 shots 590nm, 12j, 20msec, 15°c, 15×15 - full face (small area), 1 pass, 50 shots treatment was started from the right side, with slight heat was felt on the left side.No complaints of pain or heat sensation during the procedure.Patient reported experiencing tingling sensation on the entire face on the way home.Follow-up treatments were performed on: ·(b)(6) 2024.Patient reported blister formation (timing unspecified).Patient visited a nearby dermatology clinic on (b)(6) 2024.Details of treatment are unclear.·(b)(6) 2024.Patient reported a linear 3cm blister residue on the left cheekbone, with mild pain.Prescribed azunol ointment (non-steroidal anti-inflammatory), provided adhesive bandage.·(b)(6) 2024.Blisters disappeared, leaving linear post-inflammatory hyperpigmentation (pih).Administered iontophoresis (vitamin c) treatment.Prescribed synalar, l-cysteine, and tranexamic acid.·(b)(6) 2024.Pih remained.Administered iontophoresis (vitamin c) treatment.Prescribed synalar, l-cysteine, and tranexamic acid.·(b)(6) 2024 pih persisted.Administered iontophoresis (vitamin c) treatment.Prescribed synalar, l-cysteine, and tranexamic acid.Patient has been visiting the clinic weekly and continuing with previous treatments.Additionally, hydroquinone ointment and bi-weekly chemical peel treatment has been added.

• Brand Name: BBLS
• 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: 19367981
• Report Number: 2953696-2024-00035
• Device Sequence Number: 18046888
• Product Code: GEX
• UDI-Device Identifier: 00863249000312
• UDI-Public: 0863249000312
• 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): 05/21/2024

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: BBLS
• Device Catalogue Number: 1500-113-30
• Device Lot Number: 30965
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/21/2024
• Date Device Manufactured: 08/05/2019
• 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: 50 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian