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

Model Number CB-CONSOLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

Information regarding this case is currently being sought and will be updated accordingly.The investigation is underway.

Event Description

A user facility reported a burn on a patient's cheeks.The patient reported that they were okay 1 week after treatment.After the follow-up, the patient then called in and reported a burn.The patient also said they were using some sort of do it yourself tumeric on their skin.The date the patient reported the burn to the customer is unknown.

Manufacturer Narrative

The customer reported the patient was initially doing ok when they followed up 1 week after treatment, but then called them and reported the burn after the follow up.It was reported the patient had used some type of turmeric on their skin which is known to be abrasive.No treatment information provided nor was the product returned for evaluation.Solta clinical believes the use of turmeric by the patient after treatment may have led to this event.Based on the available information, this event is most likely patient related.Possible patient burns are referenced throughout the clear + brilliant laser system (p009341-03 rev.A).The system has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.Customer can also utilize the burn paper to confirm system laser is providing correct pattern/coverage.Customer did not perform requested burn paper test and thus we cannot verify proper pattern/coverage.It is the responsibility of the customer to perform the burn paper test and submit for review and if they do not there are no further actions to be taken according to clear+brilliant user manual (p009341-03 rev.A), it is essential the clear+brilliant laser system not deliver an excessive amount of energy to the patient per the selected treatment setting.Placing the system in areas where intense electromagnetic disturbances could be present may result in excessive energy delivered to the patient, or unexpected changes in treatment levels that could lead to possible burns to the patient.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Complaint type identified within risk analysis and performing within anticipated rate final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record for serial/lot number (b)(6).

• Brand Name: CLEAR + BRILLIANT LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 north creek pkwy n; suite 100; bothel WA 98011
• MDR Report Key: 12238216
• MDR Text Key: 263849204
• Report Number: 3011423170-2021-00075
• Device Sequence Number: 1
• Product Code: ONG
• Combination Product (y/n): Y
• PMA/PMN Number: K120433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CB-CONSOLE
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other