MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number	G53585
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510 (k) number: k142688.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-19-c device of lot number c1452129 involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and a document based investigation was conducted.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the 10th october 2018.On evaluation of the returned device it was noted that there was a proximal needle breakage.Proximal end of broken needle measured approx.333mm from bottom of hub.Another break was also observed and measured approx.315mm from the needle tip (specification 1705mm +2mm/-2mm).Following the laboratory evaluation additional information was requested to check if the second break had been observed during the procedure as well as the break below the sheath adjuster which the complaint refers to.No answer to this query has been received to date but the fact that a second break was not mentioned on the complaint form indicates that this second break possibly occurred as a result of re-packaging for transport returns.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 device handling or excessive force was applied causing the needle breakage when attaching or detatching the device to the scope.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 prior to distribution, all echo-hd-19-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.The review of relevant information, confirms the failure mode of needle broken has occurred.Ifu review the notes section of the instructions for use, ifu0077-4, which accompanies this device instructs the user to inspect the device prior to use : "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0077-4 ).Summary complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Needle broke 5 cm after handle during procedure."as per complaint form": during the second passage the sheath plus needle broke apart approx.5 cm after handgrip-end and remained in the working channel from the endoscope.Endoscope had to be removed from patient to remove the device externally from the working channel.A forceps was used to take sheath and needle out of working channel.Metal needle was thrown away, only sheath and handle will be sent back.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7998902
• Report Number: 3001845648-2018-00498
• Device Sequence Number: 203504
• Product Code: FCG
• UDI-Device Identifier: 00827002535855
• UDI-Public: (01)00827002535855(17)210209(10)C1452129
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2018

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: 02/09/2021
• Device Model Number: G53585
• Device Catalogue Number: ECHO-HD-19-C
• Device Lot Number: C1452129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/24/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1