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

Model Number MCSR1500-D-INTL

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

Patient Problems Burn(s) (1757); Erythema (1840); Peeling (1999); Skin Irritation (2076)

Event Date 09/05/2020

Event Type  Injury  

Manufacturer Narrative

A review of the device history records is in progress.The treatment tip will not be returned for evaluation because the fraxel treatment tips do not delivery any energy and no treatment data is stored on the tip itself; therefore no information is gathered from their return.The system has no 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 performed burn paper test and sent it to product support for review.Review of burn paper showed proper pattern/coverage.A functional/ preventative maintenance of the unit was completed, and the unit is performing in accordance with our specifications.Based on all available information, no causal factors can be determined and no conclusion can be drawn at the time of this report.

Event Description

A customer reported that a patient experienced a burn following a fraxel treatment across the patients décolletage.The patient underwent a fraxel treatment with a maximum power of 15j with 35% coverage.Eight passes were completed.During the treatment there were no system errors noted and the treatment was completed without issue.Two days following treatment, the patient reported to the physician that they experienced a burn in the treatment area.Photos of the injury were reviewed and showed severe crusting with mild secretion and moderate erythema in the treatment area.The doctor instructed the patient to use bepanthen burn cream and prescribed an unknown antibiotic.Patient current status is noted as healing, it is currently unknown if there will be permanent scarring.

Event Description

Patient also underwent led light therapy as part of their burn treatment.

Manufacturer Narrative

A review of the manufacturing records showed all requirements were met.It was reported the no system errors or anything out of the ordinary occurred during treatment.Field service attended site to evaluated system and perform functional testing.Based on the available information, burns, blisters, and redness are known possible outcomes of fraxel treatment.During evaluation, service found system was operating within specifications.Service checked all connections on the rear panel and reseated.Cleaned self-test port and handpiece glass windows.System passed laser output verification, laser output verifications, and stationary burn and functional pattern paper testing.According to the 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.

• 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: 10657869
• MDR Text Key: 210679584
• Report Number: 3011423170-2020-00092
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MCSR1500-D-INTL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention