MAUDE Adverse Event Report: ANGIODYNAMICS STARBURST ELECTRODE; ELECTROSURGICAL PROBE,,

Model Number	700-103902
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device 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 device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
A distributor reported a patient issue when using a starburst xl15cm device.After setting up the unit and taping dispersive electrodes to the patient, the procedure was started by opening the antenna 2cm.After 10 minutes of radiofrequency ablation (rfa) energy start, the unit temperature monitor only displayed 50-60 degrees celsius and temperature not to target temperature (stable at 50-60 degree celsius for all temperature indicator, watt delivery equal watt setting).The doctor requested the machine be powered off and back on.10 minutes after the machine was restarted, the monitored still displayed 50-60 degrees celsius for rfa energy.The scrub nurse looked at the patient's skin and noticed there was evidence of a burn, so the rfa energy was stopped and the starburst xl electrosurgical device was removed from the patient.The case was aborted.It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was one starburst probe.Functional testing was performed on the returned device, however, the reported complaint description could not be replicated in the lab setting.The device functioned as intended.The customer's reported complaint description could not be confirmed.Engineering evaluation ran a 150w ablation and saw no issue with the ablation itself, the device, or issues with the temperature.No excessive heat, or arcing seen.Placed device into the oven and temperatures were viewed to go up to 85.Could not duplicate any symptoms of causing a burn.Device functions as intended.A device history records search revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the instructions for use (16604121-01) 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." a review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: STARBURST ELECTRODE
• Common Device Name: ELECTROSURGICAL PROBE,,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• MDR Report Key: 10139511
• Report Number: 1317056-2020-00100
• Device Sequence Number: 16749269
• Product Code: GEI
• UDI-Device Identifier: H7877001039021
• UDI-Public: H7877001039021
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K010060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 700-103902
• Device Catalogue Number: 700103902
• Device Lot Number: 5545334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR