MAUDE Adverse Event Report: SOLTA MEDICAL INC. FRAXEL RE:STORE LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM

Model Number SYS-SR1500-D-US

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

Patient Problem Unspecified Infection (1930)

Event Date 09/24/2018

Event Type  Injury  

Manufacturer Narrative

The fraxel treatment tips do not deliver any energy and no treatment data is stored on the tip itself; there is no information to gather from their return.The exception to this would be if the fraxel tip plastic housing or component scratched the patient.For other reported events, tips are not a viable source of evaluation data.System has no system/data logs that can be reviewed.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.The investigation is ongoing.

Event Description

The user facility reported that a patient treated with the fraxel system on the chest experienced a yeast infection 2 days later.The nature of the injury was itchy, fiery red with tiny white pustules.The patient was treated with diflucan and antibiotic.There was no permanent damage or scarring and the patient is happy with her fraxel results.Nothing out of the ordinary was observed during the treatment.

Manufacturer Narrative

Additional information in event.No products were returned for evaluation.A review of the device history 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.The customer did not perform the requested burn paper testing, however,the customer used the system and the tip after this event with no issues.According to fraxel dual 1550/1927 laser system user manual (p009220-03 rev.A), infections are a known possible complication after fraxel treatment.A risk of infection exists whenever the skin is wounded.The possibility for infection exists even with non-ablative fractional laser devices such the fraxel 1550, fraxel 1927 or fraxel dual 1550/1927 laser systems.If observed, infection should be treated appropriately with topical and/or systemic medications.Local scarring may occur directly from laser exposure if treatment procedures are not followed properly, or from infection or physical irritation such as picking and rubbing.Itching and dryness could also occur.These are common symptoms once the skin has healed initially.Flakiness and dry crusting will gradually clear.Use of bland moisturizers and/or moisturizing sunscreens that have previously been shown to not cause irritation should help this condition.To prevent cross contamination during treatments, solta instructs the user to perform a high-level disinfecting procedure on treatment tips.Solta medical has tested and qualified a disinfection method using cidex opa, which disinfects the tips to the reusable medical device classification of high level disinfection for semi-critical devices.After treatment and while still attached to the handpiece, the tip should be wiped with 70% alcohol (preps) and inspected for debris and other contamination.The tip should then be removed from the handpiece and inspected again.Any remaining debris should be removed.Care should be taken not to allow debris, cleaning materials, or other contaminants to fall into the mouth of the tip.If the tip was used with off-white plastic rollers, remove used rollers and replace with new set.Multiple patient use may create the potential risk of cross contamination of biological agents from one patient to another.Based on the available information, infection is a known possible complication after fraxel treatment.No permanent damage or scarring will occur.No further investigation or corrective action is necessary.

Event Description

Additional information regarding the event was received, this was the first time the treatment tip was used.The wavelength used to perform the treatment was 1927 four 1550.There were a total of 3 reps that occurred.The highest energy level is 3.No burn paper test was performed prior to use.

• Brand Name: FRAXEL RE:STORE LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• MDR Report Key: 8069680
• MDR Text Key: 127128561
• Report Number: 3011423170-2018-00115
• Device Sequence Number: 1
• Product Code: ONG
• Combination Product (y/n): Y
• PMA/PMN Number: K101490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYS-SR1500-D-US
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1