MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP® PROCORE¿ HD ENDOBRONCHIAL BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number	ECHO-HD-25-EBUS-P-C
Medical Device Problem Codes	Retraction Problem (1536); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is related to an echo-hd-25-ebus-p-c device of lot # c1158719.The complaint device, echo-hd-25-ebus-p-c of lot# c1158719 was unavailable for return or evaluation, therefore a document based investigation was carried out.The customer complaint is considered confirmed based on customer testimony.A possible cause of this complaint is that the needle bent/kinked during use, which may be attributed to individual patient anatomy if the area being sampled was a particularly hard mass or lesion and required a more forceful advancement of the needle.It is also possible that the needle was damaged due to product handling when advancing/removing the device from the endoscope during use.As the device was not returned for evaluation and conditions of device usage cannot be replicated in the laboratory it is not possible to conclusively determine the root cause of this complaint.Prior to distribution, all echo 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 cirl.A review of the manufacturing records for echo-hd-25-ebus-p-c device of lot# c1158719 did not reveal any discrepancies that could have contributed to this complaint issue.The notes section of the instructions for use ifu0110-4 that 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".The risk for this complaint has been assessed and has been determined to be low.Another device was used to successfully complete the procedure.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
During an endoscopic ultrasonography (eus) procedure on a patient of unknown age and gender, it was noted that when the spring that pushes the needle in and out was not working properly.It seemed as if the spring had sprung.Removed the device and used another of the same to complete the procedure.

• Brand Name: ECHOTIP® PROCORE¿ HD ENDOBRONCHIAL BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 5499949
• Report Number: 3001845648-2016-00070
• Device Sequence Number: 16207678
• Product Code: FCG
• UDI-Device Identifier: 00827002342804
• UDI-Public: (01)00827002342804(17)181008(10)C1158719
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K093195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2016

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-25-EBUS-P-C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/17/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2016
• Initial Report FDA Received Date: 03/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1