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

Model Number G53408

Device Problem Material Protrusion/Extrusion (2979)

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

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k160229.(b)(4).Upon evaluation of the returned device the following was noted: device 2: brass insert protrusion on tightening thumbscrew and sheath adjuster can be moved, also the brass insert for the needle adjuster seems to be protruding and needle adjuster can be moved.The root cause of the brass insert protrusion issue is a lack of specification at the locking ring-brass insert joint.The customer complaint is considered to be confirmed as needle adjuster-brass insert protruding capa was raised in relation to the complaint issue & will deal with any actions identified.Complaints of this nature will continue to be monitored for potential emerging trends.Prior to distribution, all echo-hd-22-ebus-p devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at (b)(4).The notes section of the instructions for use, ifu0060-3, which accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".A review of the manufacturing records for echo-hd-22-ebus-p device of lot# c1282926 did not reveal any discrepancies that could have contributed to this complaint issue.From the information provided there are no adverse effect to the patient as it is prior to use.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This initial mdr is being submitted due to moderate overall risk rating in remediated dfmea.As instructed by cook (b)(4), "unused, unopened device returned under (b)(4) checked for failure mode: needle ajuster-brass insert displaced.".

• 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
• Manufacturer Contact: michael galvin ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7125497
• MDR Text Key: 95936299
• Report Number: 3001845648-2017-00596
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002534087
• UDI-Public: (01)00827002534087(17)191011(10)C1282926
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2017

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
• Device Operator: Other
• Device Model Number: G53408
• Device Catalogue Number: ECHO-HD-22-EBUS-P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/20/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1