MAUDE Adverse Event Report: ANGIODYNAMICS SOLERO MICROWAVE TISSUE ABLATION SYSTEM; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number 12740000

Device Problem Energy Output Problem (1431)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  malfunction  

Event Description

An end user reported that during testing of the first of two 19cm solero applicators, at 140w for 30 seconds,as soon as the applicator was connected to the machine, there was an "applicator temperature fault" and after 1 second of testing in the saline there was a "high reflected power" fault.The generator was rebooted, and a new probe was connected to the generator; however, the same error messages displayed.Unable to resolve the issue, the patient, who was already under general anesthesia was woken up with no treatment provided, and the procedure was rescheduled for two weeks after this event.This event meets the criteria a reportable adverse event; patient safety risk due to unneccesary sedation and treatment not provided.

Manufacturer Narrative

The reported solero unit has yet to be returned to the manufacturer for an evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Manufacturer Narrative

Returned for evaluation was solero generator, sn (b)(6).The reported complaint description of "high reflected power" was able to be duplicated during functional testing.The reported complaint description is confirmed.During functional testing, a high reflected power message appeared.The root cause for the applicator temperature fault & high reflected power was determined to be a faulty solid state generator, which was replaced.This is the first reported error of this unit for applicator temperature fault & high reflected power.This is the first time the solid state generator has been replaced.The root cause for the solid state generator fault could not be determined.The unit was tested with the new solid state generator per functional test and electrical safety test and met all acceptance criteria.A review of the device history records (service order history) was performed for the reported serial number (b)(6) for any deviations related to the reported failure mode of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution; i.E.No ncr associated with reported failure mode.Labeling review: the user manual, which is supplied to the user with this unit contains the following statements: 6.3 errors errors are non-recoverable system failures which require the end user to reboot the system.System errors may be the result of a failure that the end user in general has no ability to correct.System errors will be reported with unique error numbers which must be provided to angiodynamics to facilitate troubleshooting.In the event of a system error please make note of the events leading up to the error, record the error number, and follow the on-screen instructions.If such an error occurs, the solero unit will turn off and disable the microwave source, so there is no risk of immediate harm to the end user or the patient.6.3.2 unrecoverable system errors any system error other than the coolant fault will be the result of an underlying problem with the system that the user will be unable to correct.In this case, the system will display an error similar to the one shown (example system error 125).The only differentiation will be the error number reported in the status bar.In this event, the user should note the conditions leading up to the error, record the error number, and report this information to the complaint handling department of angiodynamics.See section 12 for contact information.System errors are unrecoverable and the system should be shut down.It is not recommended that the system be restarted for further procedures until cleared by angiodynamics.6.2.5 high reflected power the system will display a warning when the reflected power exceeds a preset threshold as shown and abort the ablation.If this occurs, microwave energy is unable to be effectively transferred from the applicator tip into the targeted tissue due to desiccation.Further progress is blocked until the warning is acknowledged.If a "high reflected power" condition is indicated, several sources are possible and warning message will be displayed as shown.The following are several possible sources leading to the "high reflected power" condition: the applicators active region may not be fully inserted into the tissue or a transient gas pocket may have formed around the applicator tip.Adjust the positioning of the applicator.Adjust time as necessary.Press start/stop button to restart the ablation.Connection to the generator may have been lost.Check the connection to the generator.Adjust time as necessary.Press the start/stop button to restart the ablation.The applicator may be defective.Replace the applicator with a new one.If the problem persists, contact angiodynamics inc.For technical support." a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: SOLERO MICROWAVE TISSUE ABLATION SYSTEM
• Type of Device: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 14928283
• MDR Text Key: 301337503
• Report Number: 1317056-2022-00090
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12740000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1