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

Model Number	G34279
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510 (k) number; k160229.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.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The needle broke during the ganglionic punction.The needle has been kink during the punction.Impossible to replace the needle in the sheath.The needle has been retrieved outside the working channel together with the scope.He met physician dr (b)(6) who performed the procedure , he confirm a hole appear up the tip of the needle, stylet was replace in the needle and when stylet was in in place near the needle tip, needle break down.
Additional Manufacturer Narrative
510 (k) number; k160229.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.This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.The returned needle was seen to be broken distally in the lab, the broken part of the needle was not returned.Complaint is confirmed as failure was confirmed during lab evaluation.Root cause (possible): as the clinical settings cannot be replicated within the laboratory, a definitive root cause for the failure cannot be determined.A possible cause for the break in the needle may be due to a hard lesion.Prior to distribution, all echo-hd-22-ebus-p-c 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-p-c device of lot number c1527151 did not reveal any discrepancies that could have contributed to the issue.The instructions for use, which accompanies this device, instructs the user to; "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".As the clinical settings cannot be replicated within the laboratory, a definitive root cause for the failure cannot be determined.A possible cause for the break in the needle may be due to a hard lesion.As per information provided, there were no adverse effects on the patient due to this occurrence.A section of the device did not remain inside the patient¿s body.It was confirmed by the rep that the needle was retrieved outside the working channel.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.Initial report details: the needle broke during the ganglionic punction.The needle has been kinked during the punction.Impossible to replace the needle in the sheath.The needle has been retrieved outside the working channel together with the scope.The physician who performed the procedure confirmed that a hole appeared at the tip of the needle, stylet was replaced in the needle and when stylet was in place near the needle tip, needle broke.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8207687
• Report Number: 3001845648-2018-00615
• Device Sequence Number: 13505793
• Product Code: FCG
• UDI-Device Identifier: 00827002342798
• UDI-Public: (01)00827002342798(17)210803(10)C1527151
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/02/2019

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: 08/03/2021
• Device Model Number: G34279
• Device Catalogue Number: ECHO-HD-22-EBUS-P-C
• Device Lot Number: C1527151
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/31/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1