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

Catalog Number	ECHO-HD-22-EBUS-P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Pma/510(k) # k160229.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.Prior to distribution, all echo-hd-22-ebus-p devices are subjected to functional checks and visual inspection to ensure integrity of the product.These inspections and functional checks are outlined in internal procedures in place at cirl.From the information provided the patient did not experience any adverse effects due to this occurrence complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
While performing ebus-tbna (3rd pass) in station 11 the needle bent.The scope was removed with the needle inside and it was noticed the needle was broken.
Additional Manufacturer Narrative
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.Pma/510(k) # k160229.1 x echo-hd-22-ebus-p was returned to cirl for evaluation.During the lab evaluation the following was noted: the stylet was out of the device on return and the needle was fully retracted.The broken park of needle was returned in a tissue.The sheath extender part of the device was not returned.The broken part o the needle measure approximately 11mm (1.6cm).The needle was removed and measured approx.94.7cm, the break was a distal break.The customer complaint is considered to be confirmed due to broken needle.Prior to distribution, all echo-hd-22-ebus-p devices are subjected to functional checks and visual inspection to ensure integrity of the product.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for echo devices of lot# c1306641 did not reveal any discrepancies that could have contributed to this complaint issue.From the information provided the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
A follow-up mdr is being submitted to include the device evaluation details.Initial report details: while performing ebus-tbna (3rd pass) in station 11 the needle bent.The scope was removed with the needle inside and it was noticed the needle was broken.

• 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: 6453200
• Report Number: 3001845648-2017-00109
• Device Sequence Number: 693554
• Product Code: FCG
• UDI-Device Identifier: 00827002534087
• UDI-Public: (01)00827002534087(17)191215(10)C1306641
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2017

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 Catalogue Number: ECHO-HD-22-EBUS-P
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/03/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 05/05/2017
• 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: Required Intervention
• Patient Weight: 75