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

Catalog Number	H7877001019301
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint reference # (b)(4).
Event or Problem Description
As reported: during an rfa procedure using a starburst rfa probe, "op" showed up on the fifth temperature window and couldn't start ablation.The procedure was aborted due to this event.As the procedure was not completed, and the patient was unnecessarily sedated, this event meets the criteria of a reportable adverse event.It was indicated the patient did not suffer any harm or injury due to the event.The reported defective device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a starburst xl 10cm probe.A visual review of the returned sample noted no obvious defects.The device was connected to a 1500x rf generator.The unit gave the message of "bad device or connection / tc5[?]".Window displays 1, 2, 3 and 4 read ambient temperatures and were observed to rise when each tine was grasped with gloved fingers.Window #5 showed "op".The reported complaint description of the temperature window of tc5 showing op is confirmed.Although the complaint is confirmed, a definitive root cause cannot be determined.Device was disassembled and inspected to find the red tc wire was broken.Tc wires are 40 awg wires and are fragile.If any kind of weakness/joint in a tc wire is created, it takes minimal movement to sever the tc wire.A device history records search revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the instructions for use, which is supplied to the user with this catalog number, contains the following statements: "verify that each of the device temperature needles is functioning by holding the temperature needles between your sterile, gloved fingers.The temperature readings on the rf generator should increase within 30 seconds.If they do not, check connections and try again." 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¿ ELECTRODE
• Common Device Name: ELECTROSURGICAL PROBE,,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 9192641
• Report Number: 1317056-2019-00138
• Device Sequence Number: 2486541
• Product Code: GEI
• UDI-Device Identifier: H7877001019301
• UDI-Public: H7877001019301
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2019
• Device Catalogue Number: H7877001019301
• Device Lot Number: 5436753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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