MAUDE Adverse Event Report: SOLTA MEDICAL, INC CLEAR + BRILLIANT LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM

Model Number	CB-CONSOLE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is underway.
Event or Problem Description
A user facility reported a burn to the patient's hand during a clear and brilliant procedure.There is no other information available at this time.A request for further information has been sent.
Event or Problem Description
Additional information was received, and it was determined that the operator of the device went against protocol by: over treating the hand by going above the 8 passes that is recommended as per our protocol.Didn¿t pre and post cool or allow for adequate thermal relaxation time during the treatment.This allowed for an accumulation of too much heat to the hand.The clinical trainer based in australia visited the clinic in scope of this adverse event, and she has concluded that the event had occurred due to the operator going against the treatment protocol.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
No other treatment information was provided by the customer and no product was returned for evaluation after multiple follow up attempts.A solta clinical training specialist found that the customer was going against training protocols during this treatment causing the event.The user was over-treating the hand by going above the 8 passes that is recommended as per the protocol.Also, the user didn¿t pre and post cool or allow for adequate thermal relaxation time during the treatment.According to the solta clinical training specialist, this allowed for an accumulation of too much heat to the hand resulting in this event.The user was re-trained on proper technique and protocols for clear+brilliant treatment.According to clear+brilliant system hazard analysis, burns are a known possible complication of treatment.No nonconformities or anomalies were found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, this event was most likely technique related.At this time, no capa is necessary.

• Brand Name: CLEAR + BRILLIANT LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC; 11720 n creek pkwy n; ste. 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste. 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 18943294
• Report Number: 3011423170-2024-00135
• Device Sequence Number: 12857329
• Product Code: ONG
• UDI-Device Identifier: 00850608002643
• UDI-Public: 00850608002643
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120433
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2024

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: CB-CONSOLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 05/14/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/08/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown