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

Model Number	G34282
Medical Device Problem Codes	Bent (1059); Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2018
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.Lab evaluation: 1 x echo-hd-25ebus-0-c device of lot # c1384037 was returned to cirl for evaluation.Upon evaluation, the device was returned in a plastic bag.The stylet was partially out on return, there was no needle exposure.There was a bend below the sheath extender, which is visible on the sheath this can be attributed to the conditions in which the device was returned.There were no issues with advancing and retracting the needle.No issue noted with the luer.There is a kink at the distal end of the needle.Microscopic pictures were taken of the needle.The customer complaint is confirmed as there was a distal kink noted on the needle during the lab 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 the needle bent when excessive force was applied possibly while advancing the needle into the target site, also the user also stated " i cannot deny the possibility that the needle penetrated cartilages, or advanced the surface of cartilage.".Documents review: prior to distribution, all echo-hd-25-ebus-0-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.Ifu review: it may be noted that according to the instructions for use, ifu0109-6, 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¿.On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.A review of the manufacturing records for echo-hd-25-ebus-0-c of lot number c1384037 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 # c1384037 upon review of complaints this failure mode has not occurred previously with this lot # c1384037.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.
Event or Problem Description
After vocal cords and subsegmental bronchus was observed by endoscopy, ebus-tbna (endoscopic ultrasound guided transbronchial needle aspiration) was performed.The user inserted and positioned olympus' bf-uc260fw at 4r (right lower paratracheal nodes).Then he inserted echo-hd-25-ebus-o-c with the stylet inserted fully and punctured the target site.It was confirmed that the some cells was collected successfully at first puncture.Then, the user attempted second puncture, however the needle did not stick in because the puncture quality of the needle was not good, so he removed the needle from the endoscope and it was confirmed that the needle bent at 2~3cm from the tip.Some cells were collected by the first puncture, so he completed the procedure without using other devices to collect more cells.[note]: the first puncture was smooth.At the second puncture, the needle was inserted into the scope smoothly, but it id not stick well.I cannot deny the possibility that the needle penetrated cartilages, or advanced the surface of cartilage.
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 to cancel the initial mdr report.After the submission of the initial report , updates were made to cook ireland¿s risk management system in accordance with iso4971.These updates included the requirement to identify the initial probability of occurrence and the individual risk levels associated with each hazard and hazardous situation.As a result of the system updates the risk documentation has been revised.The severity associated with the hazardous situation has not changed however the identified risk levels associated with distal and proximal needle kinks on echo ebus devices have reduced, and are now identified as low risk.This case were initially reported on the description of a distal needle kink.A serious deterioration in the state of health of the patient was not reported in this case.The initial assessment was based on the current risk at the time for those failure modes within the original risk documentation and the case was reported based on potential for harm to occur as per section 803.50 of 21 cfr 803 fda mdr reporting is not required.Overall risk assessed as category iia (low).H3 other text : 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 to cancel the initial mdr report.After the submission of the initial report , updates were made to cook ireland¿s risk management system in accordance with iso4971.These updates included the requirement to identify the initial probability of occurrence and the individual risk levels associated with each hazard and hazardous situation.As a result of the system updates the risk documentation has been revised.The severity associated with the hazardous situation has not changed however the identified risk levels associated with distal and proximal needle kinks on echo ebus devices have reduced, and are now identified as low risk.This case were initially reported on the description of a distal needle kink.A serious deterioration in the state of health of the patient was not reported in this case.The initial assessment was based on the current risk at the time for those failure modes within the original risk documentation and the case was reported based on potential for harm to occur as per section 803.50 of 21 cfr 803 fda mdr reporting is not required.Overall risk assessed as category iia (low).
Event or Problem Description
This follow up report is being submitted as a cancellation report.After vocal cords and subsegmental bronchus was observed by endoscopy, ebus-tbna (endoscopic ultrasound guided transbronchial needle aspiration) was performed.The user inserted and positioned olympus' bf-uc260fw at 4r (right lower paratracheal nodes).Then he inserted echo-hd-25-ebus-o-c with the stylet inserted fully and punctured the target site.It was confirmed that the some cells was collected successfully at first puncture.Then, the user attempted second puncture, however the needle did not stick in because the puncture quality of the needle was not good, so he removed the needle from the endoscope and it was confirmed that the needle bent at 2~3cm from the tip.Some cells were collected by the first puncture, so he completed the procedure without using other devices to collect more cells.The first puncture was smooth.At the second puncture, the needle was inserted into the scope smoothly, but it id not stick well.I cannot deny the possibility that the needle penetrated cartilages, or advanced the surface of cartilage.

• 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: 7298997
• Report Number: 3001845648-2018-00087
• Device Sequence Number: 13692556
• Product Code: FCG
• UDI-Device Identifier: 00827002342828
• UDI-Public: (01)00827002342828(17)200731(10)C1384037
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2018

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 Model Number: G34282
• Device Catalogue Number: ECHO-HD-25-EBUS-O-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1