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

Model Number	G34281
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2017
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.It was originally indicated that the device involved in this complaint was being returned to cook ireland for evaluation; the device has not yet been received, however, if it is returned, the device will be evaluated and the investigation will be updated.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.A possible root cause for needle breakage could be due to a torturous anatomy of excessive force used while puncturing the target site.Prior to distribution all echo-hd-22-ebus-o-c devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.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".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
The doctor was performing passes with the needle, after the third pass he noticed that the stylet was not entering the sheath so he pulled it out of the patient and took it out on a slide, the needle was broken.
Additional Manufacturer Narrative
Pma/510(k) # k160229.(b)(4).Exemption number: e2016031.(b)(4).1 x echo-hd-22-ebus-o-c was returned to cook (b)(4) for evaluation.Upon evaluation of the returned device the following was noted: the broken part of the needle was returned in a container.There was no stylet was returned.Handle of the device was out of it original packaging on return, the sheath/needle was held inside the packaging, please see imaging.The was a kink below the sheath extender.The needle measure 16.5mm.The total needle length including the broken part 101.5mm.The kink below the sheath extender may be due to the transport of the device.The customer complaint is confirmed due to the needle breakage.A possible root cause for needle breakage could be due to a torturous anatomy of excessive force used while puncturing the target site.Prior to distribution all echo-hd-22-ebus-o-c devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cook (b)(4).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".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
This follow up mdr is due to be submitted as the device was returned and evaluated.The doctor was performing passes with the needle, after the third pass he noticed that the stylet was not entering the sheath so he pulled it out of the patient and took it out on a slide, the needle was broken.
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: 3005580113.1 x echo-hd-22-ebus-o-c was returned to cirl for evaluation.Upon evaluation of the returned device the following was noted: the broken part of the needle was returned in a container.There was no stylet returned.Handle of the device was out of its original packaging on return, the sheath/needle was held inside the packaging, please see imaging.The was a kink below the sheath extender.The broken needle measure approximately 16.5mm.The length from the top of the stylet to the tip of the needle( including the broken part) approximately 101.5mm.Measurement are for information purposes only.The kink below the sheath extender may be due to the transport of the device.The customer complaint is confirmed due to the needle breakage.Lab took place on the 13 of october to measure the needle below the hub as per dwg1189.The needle without the broken part measured 97mm.Then needle length including broken part 995mm, there was no part of the needle missing.A possible root cause for needle breakage could be due to a torturous anatomy of excessive force used while puncturing the target site.Prior to distribution all echo-hd-22-ebus-o-c devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.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".A review of the manufacturing records for echo-hd-22-ebus-o-c devices of lot# c1200886 did not reveal any discrepancies that could have contributed to this complaint issue.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
This follow up mdr is due to be submitted as the device was re-evaluated.The doctor was performing passes with the needle, after the third pass he noticed that the stylet was not entering the sheath so he pulled it out of the patient and took it out on a slide, the needle was broken.

• 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: 6762799
• Report Number: 3001845648-2017-00312
• Device Sequence Number: 2013209
• Product Code: FCG
• UDI-Device Identifier: 00827002342811
• UDI-Public: (01)00827002342811(17)190210(10)C1200886
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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): 10/13/2017

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: Health Professional
• Device Model Number: G34281
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/03/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 08/11/2017; 10/13/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 09/06/2017; 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1