MAUDE Adverse Event Report: BAUSCH + LOMB 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 Septic Shock (2068)

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested yet not received.The investigation is ongoing.

Event Description

A patient suffered from septic shock and is indicating she believes it is due to a fraxel treatment received in (b)(6) 2017.The patient stated she also had a manicure/pedicure within the same time frame she had the fraxel treatment.

Manufacturer Narrative

Though requested, no additional information has been received from the reporter.The fraxel treatment tips do not delivery 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.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 provider did not perform the requested burn paper test and thus we cannot verify proper pattern/coverage.The investigation is ongoing.

Manufacturer Narrative

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.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.The rollers used in the fraxel cool roller tip, are for single patient use only.Multiple patient use may create the potential risk of cross contamination of biological agents from one patient to another.Root cause is unknown.Customer has not responded to requests for additional evaluation of the system.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 did not perform requested burn paper test and thus we cannot verify proper pattern/coverage.No product returned for evaluation, so we cannot determine proper disinfecting techniques by the customer.Septic shock is not listed risk documentation.A risk assessment was performed for this case.A review of the manufacturing 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.No corrective action required.No products returned for evaluation.Customer does not want to answer any further questions about the event.Complaint data has shown no other occurrences of septic shock relating to fraxel system.An independent medical review was performed regarding this case.Septic shock is possible, but highly unlikely with use of a fractional laser.Fraxel laser applies small holes to the skin, which can possibly introduce bacterial or viral infections.Complaint data shows this was an isolated incident.Based on available information, no causal factor can be determined, and no conclusion can be drawn.Trending will be performed to monitor this issue.No further action is required at this time.Final test verification specifications are acceptable per document number: (b)(4).No non-conformities or anomalies found related to this complaint when reviewing the device history record for serial/lot number: (b)(6).No capa is required, since there is no non-conformance.The investigation is complete.

• Brand Name: FRAXEL RE:STORE LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM
• Manufacturer (Section D): BAUSCH + LOMB; 11720 n creek parkway n; suite 100; rochester NY 14609
• MDR Report Key: 8087136
• MDR Text Key: 127852950
• Report Number: 3011423170-2018-00117
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SYS-SR1500-D-US
• 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: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1