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

Model Number 700-101930

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2019

Event Type  malfunction  

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 Description

As reported :hi" showed up on the first temperature window and "op" showed up on the fifth temperature window.The value of the second, third and fourth temperature window did not change".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.

Manufacturer Narrative

Returned for evaluation was a starburst xl probe of lot number 5471547.A visual review of the device noted no obvious visual defects.Functional check: 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 complaint description is not confirmed.The device was connected to a 1500x rf generator.The device was recognized.The temperature displays all read ambient temperatures and were observed to rise when grasped with gloved fingers.None of the windows displayed "op".The device was disconnected and reconnected multiple times with the same results.The device appears to be functioning properly.Opened up device and checked all connections and wires.Could not duplicate the reported failure.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.Labeling review: the instructions for use, (16604121-01) 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
• Type of Device: ELECTROSURGICAL PROBE,,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny NY 12801
• MDR Report Key: 9554737
• MDR Text Key: 174922984
• Report Number: 1317056-2020-00005
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: H7877001019301
• UDI-Public: H7877001019301
• Combination Product (y/n): N
• PMA/PMN Number: K010060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 700-101930
• Device Catalogue Number: H7877001019301
• Device Lot Number: 5471547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other