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

Catalog Number	H7877001039021
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the disposable device is 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 device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on september 21, 2017: during the preparation, it was reported that the starburst xl probe tines were difficult to deploy.The probe was irrigated/flushed with sterile saline preprocedure, at which time it was observed that a discolored fluid came from the line.The doctor determined not to use another xl needle as a precaution due to concerns the event would re-occur.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 a starburst xl probe.A visual review of the device noted the center array possesses some damage (bent/ kinked).The device was connected to a rita 1500x generator.The device was recognized and appears to be functioning properly.A 10ml syringe was filled with water and attached to the infusion port.A white paper towel was used to collect the water as its ejected through the tip.There was no evidence of foreign material or discoloration on the towel.The customer's reported complaint description of foreign matter in the fluid path is confirmed based off the photographic evidence provided by the complainant.During the sample evaluation, no foreign matter was observed although it's possible that there was only a small amount that was flushed out during the initial purge cycle at the customer facility.The arrays with the drive tube are ultrasonically cleaned and wiped prior to installation of the trocar.The exact cause of the dirty fluid cannot be definitely determined, although a review of trends for this failure type and product family indicates that this is considered an isolated incident.A review of the lot history records was performed for the reported packaging lot 5126590 for catalog number h7877001039021 for any deviations related to the reported defect of the complaint.The review confirmed that the packaging lot and all component lots met all material, assembly, and performance specification.The most likely root cause to the damage to the tip is due to handling.The device is inspected for damage prior to shipment.The serial number of the hardware unit used during this event was not reported by the complainant.Without a reported serial number, a review of hardware service records is not possible.Furthermore, the reported complaint type could not have been a result of an anomaly with the unit.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.Complaint reference # (b)(4).

• Brand Name: STARBURST¿ TALON ELECTRODE
• Common Device Name: ELECTROSURGICAL PROBE,
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 6935056
• Report Number: 1056436-2017-00107
• Device Sequence Number: 18947929
• Product Code: GEI
• UDI-Device Identifier: H7877001039021
• UDI-Public: H7877001039021
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K010060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: Physician
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: H7877001039021
• Device Lot Number: 5126590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1