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

Model Number	G34280
Medical Device Problem Codes	Bent (1059); Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2017
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 with the investigation conclusions.
Event or Problem Description
Needle reached endobronchial(4r) and completed first puncture then withdraw the device out of patient when the tip bent was detected.Replace a new same device to continue the procedure with tip bent again.With another new same device to complete the procedure.
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.Lab evaluation: 1 x echo-hd-25-ebus-p-c from lot number c1328131 was returned to cirl for evaluation.Upon evaluation the following was noted the device was returned in its original packaging, the stylet was partially out on return.There was no needle exposure.There was no cracking a the thumbscrews or the mlla.There is a distal bend approximately 95cm from the tip and there is a proximal bend approximately 25.8cm from the sheath extender.The needle can advance retract without any issues.An additional pr has been opened to address the proximal bend.The customer complaint is considered to be confirmed as there was a bend in the needle distally.The complaint was verified in lab.Root cause: a possible root cause for the occurrence may be due to the device hitting off the tracheal rings causing the needle to bend.Documents review: a review of the manufacturing records for echo-hd-25-ebus-p-c device of lot# c1328131 did not reveal any discrepancies that may have lead to this occurrence.There is no evidence to suggest that this issue effects the entire lot # c1328131; upon review of complaints this failure mode has not occurred previously with this lot # c1328131.Prior to distribution, all echo-hd-25-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.Ifu review: the notes section of the instructions for use, ifu0110-5 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, it states in the ifu that an olympus ebus scope is intended to be used with the device".From the information provided: the patient did not experience any adverse effects due to this occurrence complaints of this nature will continue to me monitored for potential emerging trends.
Event or Problem Description
This follow up report is being submitted due to the conclusion into the investigation of this event.Needle reached endobronchial(4r) and completed first puncture then withdrew the device out of patient when the needle tip bend was detected.Replaced with a new same device to continue the procedure with tip bent again.Then with another new same device to complete the procedure.
Additional Manufacturer Narrative
Pma/510(k) # k160229.Cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to mfr site as follows: importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Investigation is pending.A follow up mdr will be submitted with the investigation conclusions.Cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to mfr site as follows: importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Investigation is pending.A follow up mdr will be submitted with the investigation conclusions.
Event or Problem Description
Needle reached endobronchial(4r) and completed first puncture then withdraw the device out of patient when the tip bent was detected.Replace a new same device to continue the procedure with tip bent again.With another new same device to complete the procedure.

• 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: 7133671
• Report Number: 3001845648-2017-00597
• Device Sequence Number: 11090356
• Product Code: FCG
• UDI-Device Identifier: 00827002342804
• UDI-Public: (01)00827002342804(17)200220(10)C1328131
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2018

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: G34280
• Device Catalogue Number: ECHO-HD-25-EBUS-P-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/20/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/04/2017; 12/04/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/17/2018; 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 70