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

Model Number	G53408
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2018
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-p device of lot number c1478339 involved in this complaint was returned for evaluation with 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))? the curve was seen at the distal end of the needle.2.Please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).Lungs ¿ sampling node station 4r 3.Please describe the size of the intended target site.Not mentioned 4.If not with the device in question, how was the procedure performed and/or finished? the procedure was completed with the needle 5.Was the device used in a tortuous position? no 6.Are images of the device or procedure available? yes the device was returned 7.Was it damaged in packaging before removal? no 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? pentax scope 135248 11.Was the scope recently serviced / repaired? no 12.Was force required on insertion of device into scope? no 13.When was the issued noted? e.G.On advancement of the sheath/needle or on needle retraction? noticed needle retraction 14.What is the endoscope manufacturer and model number that was used with this device? pentax scope 135248 15.Was difficulty experienced while retracting the needle? on the second pass it was hard to retract 16.Was the needle able to be fully retracted before removing from the patient? yes 17.Was gaining access to the targeted site difficult? yes, it was granulomas so they can be hard 18.Was the endoscope in a flexed or twisted position at any time during the procedure? no, it was straight 19.Was needle penetration of the targeted site difficult? the second pass required a firm push to enter site 20.Was the stylet fully in place inside the needle when advancing into the targeted site? the stylet was retracted slightly as preferred by the doctor 21.Was the stylet partially removed prior to advancement of needle? yes ¿ this is their preferred technique 22.How many biopsies/passes were obtained with use of this needle? 3 passes, 30-40 punctures per pass 23.Did any section of the device detach inside the patient? no 24.If kinked below the sheath extender, did they notice the kink before placing the device into the scope? no 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? not used as a pentax scope 27.If the device is procore and it is kinked distally, is the kink at the notch / core trap? it was an ultra needle on evaluation of the returned device, the device was returned with the original packaging.Bend at distal end of needle.Syringe was not returned.Needle advances and retracts, slight resistance noted, due to bend.Visual and functional were completed.A definitive root cause for the customer complaint was determined as the stylet was not fully in place inside the needle when advancing into the targeted site, as indicated in additional information received.The user did not follow the instructions for use as the stylet was not fully in place, as per additional information received.As per instruction for use, ¿ensure the stylet is fully inserted when advancing the needle into the biopsy site." therefore the needle tip bend occurred.Prior to distribution, all echo-hd-22-ebus-p 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-p device of lot number c1478339 did not reveal any issues which could have contributed to this complaint issue.The notes section of the instructions for use, which accompanies precautions for user 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.Complaint is confirmed as the failure was verified in the laboratory.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
As per cc form : needle was used to sample node 4r which is a routine node to sample.Needle passed ok on first pass and 30-40 punctures were made.On second pass needle passes ok and 30-40 passes were made.Adequate tissue was retrieved however on passing of the third time the dr showed me how the needle has developed a curve all along the sheath and is now curved / bent out of its original shape.He straightens the tip of the needle himself to allow him to pass it into the scope in the angle he needs.The needle passes ok but on retrieval this bend / curve is back.This is of extreme concern to dr (b)(6) who is worried this continued bending if the needle will result in a needle snapping off inside a node.He has reviewed mediglobe needles as an alternative to cook needles and they do not bend so he may consider moving to them should we be unable to solve this issue of cook needles bending.He explained he sees it quite often especially with hardened nodes.

• 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: 7872276
• Report Number: 3001845648-2018-00426
• Device Sequence Number: 184684
• Product Code: FCG
• UDI-Device Identifier: 00827002534087
• UDI-Public: (01)00827002534087(17)210424(10)C1478339
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2018

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: 04/24/2021
• Device Model Number: G53408
• Device Catalogue Number: ECHO-HD-22-EBUS-P
• Device Lot Number: C1478339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/13/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1