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

Model Number	G52011
Medical Device Problem Codes	Kinked (1339); Material Perforation (2205)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2018
Type of Reportable Event	Malfunction
Additional 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 to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The needle and sheath "separated" after first "attempt" which affected second biopsy.Operator changed another same product to finish the biopsy.
Event or Problem 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.
Additional 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
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7472137
• Report Number: 3001845648-2018-00196
• Device Sequence Number: 13854940
• Product Code: FCG
• UDI-Device Identifier: 00827002520110
• UDI-Public: (01)00827002520110(17)201121(10)C1423748
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1