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

Model Number CB-CONSOLE

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is underway.

Event Description

A user facility reported an adverse event of patient burns around the nasal fold on the mouth.More details have been requested and the case will be updated accordingly.

Manufacturer Narrative

The customer did not have any other details and stated they provided the information to the solta sales representatives after it had happened.No treatment information was provided.No product was returned for evaluation after multiple follow ups.The root cause is unknown/inconclusive.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 possible patient burns are referenced throughout the clear + brilliant laser system (p009341-03 rev.A).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.Customer did not have any other details and stated they provided the information to solta sales representatives after it had happened.No treatment information provided.No product returned of evaluation.Based on the available information, no causal factors can be determined and no conclusions can be drawn.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.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; ste 100; bothel WA 98011
• MDR Report Key: 12206218
• MDR Text Key: 262895306
• Report Number: 3011423170-2021-00073
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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