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

Model Number	700101731M
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the rfa unit is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.Complaint reference (b)(4).
Event or Problem Description
An angiodynamics distributor reported that a customer had experienced an issue using an rfa generator.The provider reported an rfa generator temperature issue when attempting to treat a child's osteoid osteoma of the lower tibia.A uniblate probe was being used for this procedure.It was reported that the rfa generator would not heat past 30 degrees, goalmouth the target temperature was set at 90 degrees.The connections were verified to be correct, the unit was detecting the probe, and the display showed the rf was able to be started, patient was sedated and probe was placed.When attempting to ablate after the needle was placed, the unit was shown not to be heating, and the message " infusing power in 10 sec " and loop was displayed.The procedure was aborted due to this event.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.As the patient had been sedated and treatment was not provided, this event meets the criteria of a reportable event.It was indicated that the reported rfa generator is not available to be returned to the manufacturer for evaluation.

• Brand Name: 1500X RF GENERATOR
• Common Device Name: 1500X RADIO FREQUENCY GENERATOR
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury, ny
• MDR Report Key: 10387137
• Report Number: 1319211-2020-00050
• Device Sequence Number: 16932925
• Product Code: GEI
• UDI-Device Identifier: H787700101731M0
• UDI-Public: H787700101731M0
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K040989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2020
• Initial Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1