MAUDE Adverse Event Report: ANGIODYNAMICS 1500X RF GENERATOR; 1500X RADIO FREQUENCY GENERATOR

Model Number	700101731M
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rfa 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).Reference report # 1317056-2022-00128, pr29628 for the associated disposable device.
Event or Problem Description
Device 1 of 2 associated with this event: an end user reported an issue with a 1500x(m) rf generator.An end user reported an issue with a starburst xl 10cm long probe.Per the treating physician's account of the event: using ct image guidance, a jamshidi was advanced through the overlying skin and cortex and used to biopsy the osteoid osteoma.A rita starburst xl device advanced through the tract into the patient's osteoid osteoma and its arrays were deployed in the lesion.The starburst needle was connected to the rita 1500x electrosurgical radiofrequency generator and the following settings were entered: target temperature: 90'c power: 50wtime: 6 minutes the device worked for a moment until power reached 6w, at which time the following error message appeared on the generator: system failure 3 turn power off the generator was rebooted, and the same error message occurred after power reached 6w.The needle was connected to a second generator, at which time the following error message appeared on the generator: unrecognized device the needle was connected to the first generator and multiple additional troubleshooting steps were performed, including repositioning the grounding pads on the patient and manipulating the needle and arrays.No other starburst xl or 1500x devices were available to replace.The same "system failure 3" message continued to appear when the power increased to 6w.When power was set to 5w, the device would work for approximately 30 seconds with temperature reaching up to approximately 50'c, but then the same system failure 3 error would appear.The device was removed, and curettage of the osteoid osteoma was performed using the tip of a madison perforating bone biopsy device.The patient tolerated the procedure well.Previous information provided reported the patient had been sedated for over an hour while troubleshooting was performed.This event meets the criteria a reportable adverse event; patient safety risk due to prolonged procedure greater than 30 minutes (extended sedation).
Additional Manufacturer Narrative
Returned for evaluation was rfa unit, sn (b)(6).The reported complaint description is confirmed.System failure 3 was displayed during the functional test.The power supply was replaced and the unit calibrated.During calibration, system failure 5 appeared, which points to the rf pca to be exchanged, however, this component is unavailable at this time.Therefore, this complaint will be closed and so 39114 will manage the unit repair, final functional testing and unit disposition, whenever the component becomes available.The root cause for the system failure 3 was determined to be caused by a faulty power supply, which was replaced.This is the first reported error for this unit for system failure 3.This is the first time the power supply has been replaced.The root cause for the system failure 5 is likely a fault with the rf pca component.This is the first reported error of this unit for system failure 5.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 statement: "turn the rf generator on, using the switch on the rear panel.(if the rf generator fails the self-test, turn the rf generator off and then turn it on again.If it fails again, call your local sales representative/distributor or customer service at angiodynamics, inc.)" and "caution: only modules supplied by angiodynamics, inc.Should be plugged into the generator.Plugging in other modules may cause severe damage to the generator".It also contains the following troubleshooting statements: "system failure 3: power supply turn power off".Action: turn power off.Contact customer service." and "system failure 3: power supply turn power off".Action: turn power off.Turn power back on.If error persists, contact customer service".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).Reference report # 1317056-2022-00128, (b)(4) for the associated disposable device.

• Brand Name: 1500X RF GENERATOR
• Common Device Name: 1500X RADIO FREQUENCY GENERATOR
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 15707764
• Report Number: 1319211-2022-00046
• Device Sequence Number: 5133036
• Product Code: GEI
• UDI-Device Identifier: H787700101731M0
• UDI-Public: H787700101731M0
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K040989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 700101731M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Weight: 64 KG