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

Model Number 12740000

Device Problem Failure to Fire (2610)

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

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

The reported solero unit has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

A territory manager reported that this solero generator experienced an "error 306; forward power not within specified limits".The provider was a new surgeon at the hospital who had experience with solero from a previous facility.This case was unexpectedly scheduled, and the territory manager was unable to get there to assist, but orally went over some of the basic elements prior to the case with the surgeon.Mid-case the tm was called as they received an error 306.It was reported the unit would stop working after 8 seconds of ablating and then shut down.The probe had been placed and the tm was able to hear the applicator being activated, at which time the unit and then shut down.They would restart the unit but the same thing kept occurring.The tm was unable to provide immediate information and they were not interested in troubleshooting.The patient was on the table and they wanted an immediate answer.It was determined to abort the procedure.There was no report of the patient experiencing any adverse effects, harm, or require medical intervention as a result of this incident.The reported solero unit has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.This event meets the criteria a reportable adverse event; patient safety risk due to unnecessary sedation and treatment not provided.

Manufacturer Narrative

The reported solero unit was returned to the manufacturer for servicing.Functional check performed: performed functional test and failed step 3.6.1 due to software version 1.0.4/2.3.9/17.Replaced ronetix card part# 12740024 installed serial # (b)(6) and removed serial # (b)(6) and upgrade software 1.0.4 to 1.0.5.Performed functional test and failed step 4.8 due to pump still spinning when open pump door.Replace pump, watson marlow part# 12740003.Installed serial # (b)(6) and removed serial # (b)(6).Performed calibration and passed.Performed functional test and passed.Performed electrical safety and passed.Applied calibration sticker reminder to one year out.Unit meets all acceptance criteria.The unit was identified to return for annual pm service and software upgrade under voluntary device recall.The reported customer complaint of error 306 appearing was not confirmed.The ronetix card with the upgraded software was replaced.During the functional test, the unit failed due to the pump still spinning while the pump door was opened.The root cause for the error 306 was unable to be determined because the reported failure could not be duplicated.This is the first reported error for this unit for error 306.The root cause for the unit shutting down was unable to be determined as the reported failure could not be duplicated.This is the first reported error for this unit for unit shutting down.The root cause for the pump not stopping when the door was opened was determined to be due to a defect pump, which was replaced.This is the first reported error for this unit for pump not stopping.This is the first time the pump has been replaced.The unit was tested with the new ronetix card with updated software and new pump functional 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: "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.Ap here to enter dfu information.Nformation.Dfu information.To enter dfu information.6.1.2 turn on pump: the system will display a notification when an applicator is connected, the pump housing cover is closed, and the pump is not running as shown.Ensure the pump tubing is properly loaded and the pump clip is in place before activating the pump.The power and time setpoints may be adjusted in this state, but ablations may not be started.6.1.3 close pump cover: the system will display a notification to close the pump cover when the pump housing cover is opened and an applicator is connected.If the pump is running when the cover is opened, the system will stop it.The pump may not be restarted while the cover is open as indicated by the pump control being disabled.The power and time setpoints may be adjusted in this state, but ablations may not be started 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: 12605295
• MDR Text Key: 277361870
• Report Number: 1317056-2021-00173
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• 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
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• 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