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

Model Number	G52011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
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 device of lot number c1484243 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.If the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? no 2.Please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).Lungs a.If the lungs, which lymph node was being targeted? e.G.2r, 2l, 4r, ao, ar, 11ri, 11s etc.Station 7 3.Please describe the size of the intended target site.Standard node size 4.If not with the device in question, how was the procedure performed and/or finished? finished with this device 5.Was the device used in a tortuous position? not really 6.Are images of the device or procedure available? no 7.Was it damaged in packaging before removal? not that they were aware of 8.Was it damaged on removal from packaging? no 9.Was force required to remove the device? no 10.What is the endoscope manufacturer and model number that was used? 11.Was the scope recently serviced / repaired? no 12.Was force required on insertion of device into scope? no 13.When was the issue noted? e.G.On advancement of the sheath/needle or on needle retraction? on retraction if needle 14.What is the endoscope manufacturer and model number that was used with this device? 15.Was difficulty experienced while retracting the needle? no 16.Was the needle able to be fully retracted before removing from the patient? yes 17.Was gaining access to the targeted site difficult? no 18.Was the endoscope in a flexed or twisted position at any time during the procedure? no 19.Was needle penetration of the targeted site difficult? a little 20.Was the stylet fully in place inside the needle when advancing into the targeted site? pulled back slightly 21.Was the stylet partially removed prior to advancement of needle? yes only a tiny little bit 22.How many biopsies/passes were obtained with use of this needle? 3 with adequate sample retrieved 23.Did any section of the device detach inside the patient? they don¿t know, they believe they removed the end of the needle when removing the scope but didn¿t recover the needle tip 24.If kinked below the sheath extender, did they notice the kink before placing the device into the scope? 25.Was there difficulty or slipping experienced of the sheath extender or lock ring during use? no 26.Was there difficulty in attachment / detachment of the leur to the scope? no 27.If the device is procore and it is kinked distally, is the kink at the notch / core trap? on evaluation of the returned device, the device was returned in original packaging.It was noted tip of needle broken.Proximal kink but likely due to repackaging for transport returns.Stylet, adaptor and syringe were not returned.Visual and functional checks were completed.Needle advances and retracts with slight resistance.Sheath adjuster advanced and retracted without issue.Needle section outside of sheath when advanced was measured at 3cm (reference 45.0mm, +/- 3mm ), therefore the breakage occurred at 1.5cm.The needle position was at position 5 and the sheath adjuster was at position 3.Complaint is confirmed as the failure was verified in the laboratory.Root cause: a definitive root cause for the customer complaint was determined as combination of hard lesion and stylet partially removed.The user did not follow the instructions for use as the stylet was not fully in place, as per additional information received the stylet was pulled back slightly and partially removed 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.Additionally it is possible that the needle tip breakage occurred due to hard lesion.Prior to distribution, all echo-hd-22-ebus-o 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.There is no evidence to suggest that this issue affects the entire lot # c1484243; upon review of complaints this failure mode has not occurred previously with this lot # c1484243.The notes section of the instructions for use, which accompanies precautions: ¿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.Complaint is confirmed as the failure was verified in the laboratory.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
Needle broke off during procedure.Action taken: biopsy forceps used to retrieve.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7842623
• Report Number: 3001845648-2018-00408
• Device Sequence Number: 19193746
• Product Code: FCG
• UDI-Device Identifier: 00827002520110
• UDI-Public: (01)00827002520110(17)210514(10)C1484243
• 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): 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: G52011
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Device Lot Number: C1484243
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention