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 Code	Blister (4537)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On apr 23, 2024, the following information was reported by the clinic to sciton clinical specialist: patient information: age: 45 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: bbl treatment was administered by the physician for overall facial rejuvenation and improvement of pigmentation.590nm, 8j, 20msec, 15°c, 15×45 - full face (large area), 1 pass, 60 shots 590nm, 10j, 20msec, 15°c, 15×15 - full face (small area), 1 pass, 40 shots 515nm, 15j, 10msec, 20°c, 7mm - spot treatment for pigmentation, 60 shots.Treatment started from the right side, with slight heat felt on the left side.No complaints of pain or heat sensation during the procedure, but patient reported flushing and tingling sensations post-procedure.Following the bbl treatment, iontophoresis (vitamin c) was administered.Subsequently, the patient reported blister formation during face washing (between the left nose and cheekbone).It was reported that the treatment included cooling, application of desonide cream on the left side and lindane cream (betamethasone valerate gentamicin sulfate) on the right side, blister drainage, and protection with mepilex dressing.Prescriptions included lindane cream (betamethasone valerate gentamicin sulfate), azunol (dimethyl isopropylazulene), vitamin c, tranexamic acid (tranexamic acid), and yubera (tocopherol acetate).Patient did not return for follow-up appointments as patient travelled abroad.
Additional Manufacturer Narrative
On april 19th, 2024, sciton 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.

• 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: 19367980
• Report Number: 2953696-2024-00036
• Device Sequence Number: 7618432
• 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
• 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: 45 YR
• Patient Sex: Unknown
• Patient Race: Asian