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

Model Number	G52011
Medical Device Problem Codes	Bent (1059); Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # 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 pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Product did not work as expected.Rep doesn't have further info.Product available in purchasing dept."as per complaint form": customer opened the package.Removed the system (ebus needle) out of the package.He tried to move the sliding sheath adjuster in-front of the endoscope.But it's not working, the sheath adjuster stuck at the system.After this he tried to remove the stylet.But it wasn't possible.He pulled harder, without success.After the third try the stylet came out of the system and was completely destroyed.The customer used a new cook set with the same lot number and the product works well.
Event or Problem Description
Product did not work as expected.Rep doesn't have further info.Product available in purchasing dept."as per complaint form": customer opened the package.Removed the system (ebus needle) out of the package.He tried to move the sliding sheath adjuster in-front of the endoscope.But it's not working, the sheath adjuster stuck at the system.After this he tried to remove the stylet.But it wasn't possible.He pulled harder, without success.After the third try the stylet came out of the system and was completely destroyed.The customer used a new cook set with the same lot number and the product works well.
Additional Manufacturer Narrative
Pma/510(k) # k160229 (b)(4).Exemption number: e2016031 (b)(4) lab evaluation: 1 x echo-hd-22-ebus-o was returned to cook (b)(4) for evaluation.Upon evaluation, the device was returned in its original packaging and the syringe was not present upon return.The adaptor was returned along with the stylet cap which was returned in a vial.There was no needle exposure upon return.The stylet was significantly out on return.The needle could not advance and the needle was crumpled in the handle.All parts of the needle are intact.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.However it is possible that excessive force was applied causing the needle to crumple which led the stylet cap to come off.Documents review: 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 cook (b)(4).Ifu review: it may be noted that according to the instructions for use, ifu0051-7, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.A review of the manufacturing records for echo-hd-22-ebus-o of lot number c1385717 did not reveal any discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1385717 upon review of complaints this failure mode has not occurred previously with this lot # c1385717.Summary: from the information provided, no adverse effects to the patient have been reported as a result of 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: 7147532
• Report Number: 3001845648-2017-00624
• Device Sequence Number: 13736263
• Product Code: FCG
• UDI-Device Identifier: 00827002520110
• UDI-Public: (01)00827002520110(17)200803(10)C1385717
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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
• Operator of Device: No Information
• Device Model Number: G52011
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/27/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1