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

Model Number	G52011
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k160229.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
User check the device function before use when found out the needle is difficult to pull out.After the needle was pull out , it cannot be retracted afterward.No use on patient.
Event or Problem Description
This report is being submitted as a cancellation report.Initial report details: user check the device function before use when found out the needle is difficult to pull out.After the needle was pull out , it cannot be retracted afterward.No use on patient.Additional information provided on 06-sep-19 indicated that it is stylet which was difficult to pull out and not the needle.Based on review of additional information provided and the completed investigation this complaint no longer meets the fda mdr reporting criteria of a malfunction or serious injury report.
Additional Manufacturer Narrative
This report is being submitted as a cancellation report.Based on review of additional information provided and the completed investigation this complaint no longer meets the fda mdr reporting criteria of a malfunction or serious injury report.Investigation details: complaint device was not returned therefore a document based review will be performed.It had been indicated that 1 x echo-hd-22-ebus-o of lot number c1593827 was going to be returned but to date this has not occurred.Clarification was requested to determine if it was the needle or stylet which the user had difficulty with and this was confirmed to be the stylet.Prior to distribution, all echo-hd-22-ebus-o 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-22-ebus-o of lot number c1593827 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1593827.The notes section of the instructions for use, 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".There is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause for the customer complaint could not be determined from the available information.Due to limited information and non-return of the device a possible root cause could be attributed to general handling.Complaint is confirmed based on the customer's testimony.According to the initial reporter, 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.

• 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: 8915484
• Report Number: 3001845648-2019-00425
• Device Sequence Number: 2753381
• Product Code: FCG
• UDI-Device Identifier: 00827002520110
• UDI-Public: (01)00827002520110(17)220311(10)C1593827
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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 Expiration Date: 03/11/2022
• Device Model Number: G52011
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Device Lot Number: C1593827
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1