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

Model Number CB-HP-1927

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

No additional information has been received.The product identification information has not been provided by the user facility.The device has not been returned for evaluation.Additional information has been requested from the reporter, who indicates that she is out of the country for some time and will reply on her return.

Event Description

A user facility in (b)(6) reported that a patient developed blisters on the hand one day after a clear + brilliant laser treatment.Additional information has been requested.No additional information has been received.

Manufacturer Narrative

The device history record was reviewed.The final test verification specifications are acceptable.No nonconformities or anomalies were found related to this complaint when reviewing the device history record for serial/lot number (b)(4).Manufacturing date: 03/18/2016.The clear+brilliant treatment tips do not deliver any energy and no treatment data is stored on the tip itself.Therefore, there is no information to gather from their return.The system has no system/data logs that can be reviewed.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.The provider can also utilize the burn paper to confirm system laser is providing correct pattern/coverage.The customer indicated that the burn test performed prior to the treatment showed no issues, which confirms pattern/coverage.According to clear+brilliant risk assessment (sha-09-004 rev.I), discoloration, burns, blisters, redness, and swelling are a possible side effect from treatment.It was reported that no system errors or anything out of the ordinary occurred during treatment.Based on the available information, burns, redness, and swelling are a possible side effect from treatment.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The investigation is complete.

Event Description

Additional incident information was received from the provider on (b)(6)2018.The patient was treated on the hand on (b)(6)2018 and symptoms were noticed on (b)(6)2018.The blister broke the following day.The provider is unsure if secondary intervention was required to treat the blister.No other treatments were performed in the same symptom area within the past 30 days.The highest energy level used was medium.Patient was treated with the 1927, 8 passes on level medium.The provider did not notice any system errors or anything out of the ordinary during the treatment.The provider stated that this treatment was the first time using the treatment tip, and that a burn pattern test performed prior to using the tip indicated no issues.The provider is unsure of the patient''s current status, but believes that there will be permanent damage or scarring.

• Brand Name: CLEAR + BRILLIANT LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Manufacturer (Section D): SOLTA MEDICAL; 11720 n creek parkway n; suite 100; bothell WA 98011
• MDR Report Key: 7852361
• MDR Text Key: 119436729
• Report Number: 3011423170-2018-00090
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CB-HP-1927
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1