MAUDE Adverse Event Report: ANGIODYNAMICS STARBURST TALON; RITA STARBURST TALON SEMI-FLEX ELECTROSURGICAL DEVICE

Catalog Number	700102845
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
1st talon probe: an angiodynamics territory manager reported a few "issues." it was, reportedly, hard to tell if the issues were the 25cm talon semiflex probes or a combination of probes and the intelliflow pump, or the rfa unit.The account indicated that water was everywhere but they noticed no holes in the tubing.Ultimately, the procedure was completed with a third probe.There was no harm experienced by the patient; however, the case was delayed over an hour while the patient was under general anesthesia.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
The starburst talon probe has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4) reference the following for each device used during the procedure: (b)(4) rfa generator 1319211-2023-00063 (b)(4) intelliflow pump 1319211-2023-00064 (b)(4) talon probe 1317056-2023-00135 (b)(4) talon probe 1317056-2023-00139.
Additional Manufacturer Narrative
Reference (b)(4) reference the following for each device used during the procedure: (b)(4) rfa generator 1319211-2023-00063, (b)(4) intelliflow pump 1319211-2023-00064, (b)(4) talon probe 1317056-2023-00128, (b)(4) talon probe 1317056-2023-00129.
Event or Problem Description
Based on new information received, this complaint file is being cancelled.It was confirmed that this complaint file was a duplicate of a previously reported complaint.Section h10 has the corrected complaint file reference.Therefore this report is being submitted to close out the file.

• Brand Name: STARBURST TALON
• Common Device Name: RITA STARBURST TALON SEMI-FLEX ELECTROSURGICAL DEVICE
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17987047
• Report Number: 1317056-2023-00135
• Device Sequence Number: 15268912
• Product Code: GEI
• UDI-Device Identifier: H7877001028451
• UDI-Public: H7877001028451
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K010060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 700102845
• Device Lot Number: 5751616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown