MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-01 for SOLERO MICROWAVE TISSUE ABLATION SYSTEM H78712740000 manufactured by Angiodynamics.
[164598347]
The solero generator (sn (b)(4)) involved in the incident has been returned for evaluation. The unit was returned in good physical condition. Error 0001 was confirmed during functional testing. As a correction, the ronetix card has been replaced. Unit was retested. No issues noted. Unit meets all acceptance criteria. The reported complaint description is confirmed. During functional testing, error 0001 appeared. The root cause for the error 0001 was determined to be a defective ronetix card, which was replaced. This is the first reported error of this unit for error 0001. This is the first time the ronetix card has been replaced. A review of the device history records was performed for the serial number (b)(4). The review confirms that the unit met all material, assembly, and performance specifications. 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. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[164598348]
As reported: a female patient presented for a microwave ablation of the liver. When prepping for the procedure, the solero unit displayed an "error 0001". Several attempts were made to reboot the system, but were unsuccessful. The procedure was not able to be performed. Patient was under sedation at the time of event. This event meets the criteria of a reportable event as no treatment was provided and patient had been sedated. Potential patient safety risk due to unnecessary sedation. It was reported the solero unit is available for return to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317056-2019-00134 |
| MDR Report Key | 9265548 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-01 |
| Date of Report | 2019-11-01 |
| Date of Event | 2019-10-03 |
| Date Mfgr Received | 2019-10-04 |
| Date Added to Maude | 2019-11-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAW RYAN |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLERO MICROWAVE TISSUE ABLATION SYSTEM |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2019-11-01 |
| Returned To Mfg | 2019-10-16 |
| Model Number | H78712740000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US 12801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-01 |