MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number G34785

Device Problems Bent (1059); Kinked (1339); No Apparent Adverse Event (3189)

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

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

The 510(k) number: k142688.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The device was used for eus-fna.The first device ((b)(4)): the needle was advanced from the duodenum bulb to the pancreas head.At the second attempt of biopsy, the distal luer lock could not be attached to fujifilm's endoscope properly.Therefore, the device was replaced with another echo-hd-3-20-c.The second device ((b)(4)): biopsy was contined with the second device though, the distal luer lock could not be attached to the endoscope properly.Therefore, olympus's device was used instead to complete the procedure.There have been no adverse effects to the patient reported.

Manufacturer Narrative

510(k) number: k142688.(b)(4).Exemption number: e2016031 (b)(4).This follow up mdr is being submitted to cancel the initial mdr report.A conservative assessment deemed this event reportable based on the needle kinking distally.However, following device evaluation the bend noted on the device is a natural procedure curvature and not a kink.This event has been re-assessed and this report is to notify the fda that this event no longer meets the fda reporting criteria of a malfunction report.No adverse effects to the patient was reported as occurring.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up mdr is being submitted to cancel the initial mdr report.A conservative assessment deemed this event reportable based on the needle kinking distally.However, following device evaluation the bend noted on the device is a natural procedure curvature and not a kink.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7250810
• MDR Text Key: 99925916
• Report Number: 3001845648-2018-00046
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)200419(10)C1347739
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/06/2018
• Event Location: Hospital
• Date Manufacturer Received: 01/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1