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

Model Number	700-101320
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.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.Complaint reference # (b)(4).
Event or Problem Description
As reported : the generator prompted for failure when the electrode enters the patient's body.Two (2) needles used during this procedure had the same issue.The procedure was aborted due to this event.This event meets the criteria for reportability as the patient was sedated and the procedure was not completed; patient safety risk of unnecessary sedation.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 were two starburst xl probes of lot number 5434948.Visual/microscopic exam: a visual review of the device noted no obvious visual defects.Functional check: sample #1 the device was connected to a 1500x rf generator.Window displays 1, 2, 3,4 and 5 read ambient temperatures and were observed to rise when each tine was grasped with gloved fingers.Sample #2 the device was connected to a 1500x rf generator.Window displays 1, 2, 3,4 and 5 read ambient temperatures and were observed to rise when each tine was grasped with gloved fingers.The customer's reported complaint description was not confirmed.The root cause could not be determined; the defect was not repeated, and no issues found during testing.Both the devices were connected to a 1500x rf generator.Window displays 1, 2, 3,4 and 5 read ambient temperatures and were observed to rise when each tine was grasped with gloved fingers.Opened up the device and checked all connections and wires.Could not duplicate the reported failure.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 device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.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 NY 12801
• MDR Report Key: 9554843
• Report Number: 1317056-2020-00004
• Device Sequence Number: 2914306
• Product Code: GEI
• UDI-Device Identifier: H7877001013201
• UDI-Public: H7877001013201
• 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): 02/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 700-101320
• Device Catalogue Number: H7877001013201
• Device Lot Number: 5434948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/28/2020
• 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