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

Model Number	G34282
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.Device evaluation the echo-hd-25-ebus-o-c device of lot number c1238302 device involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.Additional information was received as follows: 1.1.1 if the report involves a kink or bend in the needle, where is this located on the device (handle end or patient end)? n/a no bend/kink reported 1.1.2 please describe the location in the body for the intended target site (pancreas, stomach, etc).Lungs (probably for a lymph) 1.1.3 please describe the size of the intended target site.Unknown, probably <1cm 1.1.4 what is the endoscope manufacturer and model number that was used with this device? fujinon, model unknown 1.1.5 was gaining access to the targeted site difficult? yes, needle would not extend 1.1.6 was the endoscope in a flexed or twisted position at any time during the procedure? probably not 1.1.7 was needle penetration of the targeted site difficult? yes 1.1.8 was the stylet in place inside the needle when advancing into the targeted site? yes 1.1.9 how many biopsies were obtained with use of this needle? no 1.1.10 did any section of the device detach inside the patient? no 1.1.11 was the needle fully retracted when the device was removed from the patient? yes 1.1.12 if not, with the device in question, how was the procedure performed and/or finished? removed needle from scope and used another device successfully the complaint device underwent a laboratory evaluation on the 05th september 2018.On evaluation of the returned device it was noted that there was proximal kink possibly due to repackaging for transport returns.Needle crumpled and broke in the handle.Stylet wavy due to crumpling of needle.Syringe and adaptor was missing.Needle would not advance.Visual and functional method was used to determine the defects.Length of broken part of needle from distal side of hub measured 84mm, remainder length of needle measured 910 mm.Incorrect scope was used, as per additional information received, however this did not contribute to product failure.Complaint is confirmed as the failure was verified in the laboratory.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 breakage, thereafter causing needle advancing issue.A capa has been initiated to document and track the actions taken to investigate and to address kinking or breaking of the sheath at the sheath/sheath extender junction the scope of the capa includes; needle breaking, kinking or crumpling within the handle assembly kinking or breaking of the sheath at the sheath/sheath extender junction document review a review of the qc records did not reveal any issues which could have contributed to this complaint issue.Prior to distribution, all echo-hd-25-ebus-o-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-25-ebus-o-c device of lot number c1238302 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 #c1238302 upon review of complaints this failure mode has not occurred previously with this lot # c1238302.Ifu review the precautions section of the instructions for use ifu0109-5 that 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 also mentions in the precautions section; ¿when targeting multiple sites, replace device for each site.¿ there is no evidence to suggest that the customer did not follow the instructions for use (ifu0109-5).Summary according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
As reported to customer relations: "when placed down the scope, needle would not come out of the sheath.Removed needle from scope and used another device successfully.".

• 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: 7929964
• Report Number: 3001845648-2018-00463
• Device Sequence Number: 16506178
• Product Code: FCG
• UDI-Device Identifier: 00827002342828
• UDI-Public: (01)00827002342828(17)190603(10)C1238302
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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 Expiration Date: 06/03/2019
• Device Model Number: G34282
• Device Catalogue Number: ECHO-HD-25-EBUS-O-C
• Device Lot Number: C1238302
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/05/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1