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	06/27/2018
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.Device evaluation: the echo-hd-22-ebus-o-c device of lot number c1245122 involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.Additional information was received as follows: 1.Did the broken needle tip fall into the patient? no it was recovered from within the working channel during reprocessing 2.If so how was it retrieved? n/a 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)? patient end 1.1.2 please describe the location in the body for the intended target site (pancreas, stomach, etc).Station 11r 1.1.3 please describe the size of the intended target site.2.5 -3cm 1.1.4 what is the endoscope manufacturer and model number that was used with this device? olympus 1.1.5 was gaining access to the targeted site difficult? n 1.1.6 was the endoscope in a flexed or twisted position at any time during the procedure? y 1.1.7 was needle penetration of the targeted site difficult? y 1.1.8 was the stylet in place inside the needle when advancing into the targeted site? n 1.1.9 how many biopsies were obtained with use of this needle? 0 1.1.10 did any section of the device detach inside the patient? unsure! tip broken but was recovered from endoscope 1.1.11 was the needle fully retracted when the device was removed from the patient? y 1.1.12 if not, with the device in question, how was the procedure performed and/or finished? second echo-hd-22-ebus-o-c on evaluation of the returned device, the device was returned in original packaging.It was noted needle broken distally approximately 2cm from tip.Device was returned without the adaptor.Stylet would not pass beyond breakage.Complaint is confirmed as the failure was verified in the laboratory.Root cause: the root cause was that the user error did not follow the instructions for use as the stylet was not in place inside the needle when advancing into the targeted site.As per instruction for use, precautions: ¿ensure the stylet is fully inserted when advancing the needle into the biopsy site.¿ stylet provides needle support and provides additional support during puncture.Therefore hard lesion as indicated led to needle breakage.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-22-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.A review of the manufacturing records for echo-hd-22-ebus-o-c device of lot# c1245122 did not reveal any discrepancies that could have contributed to this complaint issue.An nc was noted on the work order, however this was subsequently re- worked and would not have attributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1245122 ; upon review of complaints this failure mode has not occurred previously with this lot # c1245122.It may be noted that according to the instructions for use, ifu0109-5, the user is instructed to: ¿ensure the stylet is fully inserted when advancing the needle into the biopsy site.¿ there is evidence to suggest that the customer did not follow the instructions for use (ifu0109-5).Summary: complaint is confirmed as the failure was verified in the laboratory.The risk associated with the complaint is risk category iii- no risk.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 tip broke at approximately 1 cm whilst sampling a tough 11r node."as per complaint form": dr (b)(6) was using the ebus-o-c device for the first time after receiving demo equipment in back in 2017.He was attempting to sample an enlarged peripheral node at 11r, after his usual supplier of needles was unable to supply his usual equipment.Dr (b)(6) described feeling the node extremely difficult to puncture on the first pass, and the device feeling clunky with resistance.After receiving no tissue he attempted a second pass where something "felt wrong".The device was removed and a second used to complete the procedure.After discussing the proper technique required for the pc device, it was apparent dr (b)(6) had removed the stylet prior to his initial pass into 11r.I explained why this is the incorrect procedure for procore, he also then recalled mark informing him of this during his initial conversation.Upon inspecting the device, the needle tip is completely sheared from the device, at approximately 1 cm however, this was retrieved, during scope sterilisation.And will be returned with the device in question.Moving forward all consultants have agreed to have me present during their initial cases.

• 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: 7714414
• Report Number: 3001845648-2018-00338
• Device Sequence Number: 13770422
• Product Code: FCG
• UDI-Device Identifier: 00827002342811
• UDI-Public: (01)00827002342811(17)190627(10)C1245122
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 07/24/2018

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: 06/27/2019
• Device Model Number: G34281
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Device Lot Number: C1245122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1