MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number G52011

Device Problems Kinked (1339); Material Perforation (2205)

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

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

The 510(k) number: k160229.(b)(4).(b)(6).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The needle and sheath seperated after first attemp which affected second biopsy.Operator changed another same product to finish the biopsy.

Event Description

This follow up report is being submitted to cancel the initial report.The needle and sheath seperated after first attemp which affected second biopsy.Operator changed another same product to finish the biopsy.

Manufacturer Narrative

510(k) number: k160229.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).This follow up report is being submitted to cancel the initial mdr report.A conservative assessment deemed this event reportable based on the malfunction precedence "distal tip needle/ sheath perforation".However, following the device evaluation no perforation was observed.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.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7472137
• MDR Text Key: 107580855
• Report Number: 3001845648-2018-00196
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002520110
• UDI-Public: (01)00827002520110(17)201121(10)C1423748
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52011
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/30/2018
• Event Location: Hospital
• Date Manufacturer Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1