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

Catalog Number	ECHO-HD-22-EBUS-P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is related to an echo-hd-22-ebus-p device of lot# c1146442.The echo-hd-22-ebus-p device involved in this complaint has not been returned for evaluation.With the information provided, a document based investigation was carried out.The customer complaint is considered confirmed based on the customer testimony.A possible cause of this complaint is that the distal needle tip kinked during use which in turn resulted in distal needle tip breakage upon removal of the needle from the lesion.The needle can kink/bend due to product handling during the procedure.A needle kink/bend may also be attributed to patient anatomy if the lesion being punctured was a hard lesion or if the endoscope was used in a tortuous anatomy.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-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# c1146442 did not reveal any discrepancies that could have contributed to this complaint issue.The notes section of the instructions for use ifu0060-2 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." according to the initial reporter, the physician retrieved the broken off piece from the patient.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
During the procedure, the distal end of the needle broke.A section of the device remained inside the patients body and this required surgical intervention (repeat ebus guided tbna) to remove the needle.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL ULTRASOUND NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 5488462
• Report Number: 3001845648-2016-00063
• Device Sequence Number: 18900113
• Product Code: FCG
• UDI-Device Identifier: 00827002534087
• UDI-Public: (01)00827002534087(17)180901(10)C1146442
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/11/2016

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?: No
• 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: 02/08/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2016
• Initial Report FDA Received Date: 03/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80