MAUDE Adverse Event Report: ANGIODYNAMICS STARBURST¿ TALON ELECTRODE; ELECTROSURGICAL PROBE

Model Number	700-102845
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device 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 or Problem Description
A distributor reported an issue with a talon 25cm semiflex probe.During an rfa of the liver, when the talon probe was placed, it was reported there was no resistance when entering the lesion.In the first two "sales", there was no resistance when opening the tip.The provider needed to change positions, so withdrew the probe, at which time it was noticed the tip of the probe was missing.It was suspected the tip was retained inside the patient, so the provider first "opened/dissected" the probe shaft with a tool, where they found the needle/tip was in the needle tube/probe tube.It was also reported that the probe had displayed "op" showed on the number 1 temperature window.The procedure was completed with a new of the same device.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.
Additional Manufacturer Narrative
Returned for evaluation was one talon probe.As received, the talon probe was in pieces and did not have the whole trocar shaft, i.E.Distal tip.The device was used as stated.It appears the first break occurred near the tip.This part of the device is not flexible.The break is from excess force in a lateral direction however, without receiving the whole trocar it is unclear to definitely determine the cause.It is most likely due to excessive lateral forces in an area of the trocar that is not flexible.Only the black peek tubing area is semi-flexible.The op in tc 1 is likely due to the damage to the device.The device is tested for connection after assembly and issues of that nature would be detected.A review of the device history record was performed for the talon probe lot for any deviation in manufacturing process related to the reported defect of the complaint.The review confirmed that the lot and the associated components used within the lot all conformed to manufacturing processes and testing.The customer's complaint description was not confirmed for op error message, due to the returned condition of the device.However, the customer's complaint description was confirmed for tip detached based on report that customer "opened/dissected" the probe.A definite root cause cannot be determined, however, the potential root cause is damage to array tines during initial use.Labeling review: the instructions for use which is supplied to the user with this catalog number contains the following statements: "inspect the device for any damage.Do not use a device that has been damaged.Fully retract the device needles by moving the slide on the handle backward (towards the cable connector) until it stops.Deploy the device needles by moving the slide forward (towards the trocar) on the handle to the desired deployment size.Upon completion of the desired ablation, turn the rf power off.Fully retract the device needles by pulling the slide on the handle backward (towards the cable connector) until it stops.For each additional ablation: verify the geometry of the array of needles between each ablation." do not attach anything (i.E., clamps, etc.) to the device.This may damage the insulation, which could contribute to patient injury.Reprocessing may compromise the integrity of the device and / or lead to device failure.Inspect the device for any damage.Do not use a device that has been damaged.Inspect the tubing set prior to use, do not use the tubing set if there is any evidence of damage (e.G., kinked, cracked, leaking, etc.).Verify the connections between tubing set and device are secure.Load the tubing set onto the reusable occlusion bed as shown above.Turn pump on.See intelliflow pump instructions for use for more details." 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: STARBURST¿ TALON ELECTRODE
• Common Device Name: ELECTROSURGICAL PROBE
• 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: 13840071
• Report Number: 1317056-2022-00056
• Device Sequence Number: 4731618
• Product Code: GEI
• UDI-Device Identifier: H7877001028451
• UDI-Public: H7877001028451
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 05/31/2024
• Device Model Number: 700-102845
• Device Catalogue Number: 700102845
• Device Lot Number: 5681011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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