MAUDE Adverse Event Report: SOLTA MEDICAL FRAXEL DUAL 1550/1927 LASER SYSTEM & ACCESSORIES; POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM

Model Number SYS-SR1500DUSLN

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

Patient Problems Erythema (1840); Idioventricular Rhythm (1923); Partial thickness (Second Degree) Burn (2694)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

A review of the device history records is in progress.The system has no system/data logs that can be reviewed, and therefore will not be returned for evaluation.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A physician¿s assistant reported that a patient underwent a fraxel 1550 treatment and experienced a 2nd degree burn blister of the glabella area.The patient was instructed to not pop the blister but keep the area very moist with aquaphor.The patient contacted the treating office and stated the blister popped the evening after the procedure.The patient was evaluated by the treating office and was given mupirocin bid to use until the epithelium heals over, then switch to cloderm bid.The current status was noted as blister is healing with an unknown outcome at this time.The available images were reviewed, a large blister is visible in the glabella area that has turned into a crust with oozing.The patient was treated with 8 passes of the laser in the treatment area at a maximum power level of 7.There were no system errors or anything out of the ordinary during the treatment.There was no burn paper test performed prior to treatment.The treatment tip was used on previous patients that day.

Manufacturer Narrative

According to fraxel user manual (p09220-03 rev.A) burns, blisters, and redness are known possible complications to treatment.Blistering or burns may develop over the treated areas.Mild-moderate transient erythema is an expected response.However, if erythema is severe or persists significantly longer than expected, re-treatment should be avoided until the condition resolves.Reaction may vary on a patient-by-patient basis.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 performed burn paper test and sent it to product support for review.Review of burn paper showed proper pattern/coverage.A review of the manufacturing records showed all requirements were met.It was reported no system issues or anything out of the ordinary occurred during treatment.During evaluation, service found system was operating within specifications.Based on the available information, burns, blisters, and redness are known possible outcomes of fraxel treatment.

• Brand Name: FRAXEL DUAL 1550/1927 LASER SYSTEM & ACCESSORIES
• Type of Device: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Manufacturer (Section D): SOLTA MEDICAL; 11720 north creek pkwy; suite 100; bothell WA 98011
• MDR Report Key: 11132495
• MDR Text Key: 225572905
• Report Number: 3011423170-2021-00004
• Device Sequence Number: 1
• Product Code: ONG
• Combination Product (y/n): Y
• PMA/PMN Number: K091420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYS-SR1500DUSLN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention