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

Model Number G53408

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

510(k) number: k160229.(b)(4).(b)(6).(b)(4).Device evaluation the echo-hd-22-ebus-p device of lot number c1477783 involved in this complaint was not returned for evaluation.With the information provided, a document based investigation was conducted.Based on sales representative testimony, needle could not be fully retracted.Additional information was received as follows; 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.Please describe the location in the body for the intended target site (pancreas, stomach, etc).Trachea.Please describe the size of the intended target site.Unknown.What is the endoscope manufacturer and model number that was used with this device? see main report.Was gaining access to the targeted site difficult? n/a.Was the endoscope in a flexed or twisted position at any time during the procedure? n/a was needle penetration of the targeted site difficult? no.Was the stylet in place inside the needle when advancing into the targeted site? yes how many biopsies were obtained with use of this needle? unknown.Did any section of the device detach inside the patient? no.Was the needle fully retracted when the device was removed from the patient? yes.If not, with the device in question, how was the procedure performed and/or finished? new one of the same.The customer complaint is considered to be confirmed based on customer testimony.Root cause: a definitive root cause for the customer complaint could not be determined due to limited information received and without device evaluation and photos, operating reports, x-rays or scans.However it is possible that the user may have damaged the device during use or the needle tip may have come into contact with a hard lesion causing the needle to become deformed and blunt at distal tip.Additionally another possible root cause could be a trachea ring was hit during the procedure causing the needle deformation.Document review: a review of qc records for did not reveal any issues which could have contributed to this complaint issue.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 c1477783 did not reveal any issues which could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1477783; upon review of complaints this failure mode has not occurred previously with this lot # c1477783.The notes section of the instructions for use, which 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.¿ there is no evidence to suggest that the customer did not follow the instructions for use.Summary: the customer complaint is considered to be confirmed based on customer testimony.The risk associated with this complaint is risk category iii/no risk.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 Description

As per cc form on sampling station 7 with a 22g ultra cook needle they battled to get the needle into the node, the needle was so blunt it deformed on entering the node and we could not remove the trochar.All the needle and scope needed to be removed together.The needle was deformed into a zig zag along the distal tip.We then switched to a competitor needle from mediglobe that produced beautiful samples with minimal effort and no needle deflection.I am this concerned that we are not using the ideal needles and need to review our equipment.Additional information received 07/20/2018 - customer confirmed 'needle retraction issue'.Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿non retraction of needle'.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7788629
• MDR Text Key: 117833558
• Report Number: 3001845648-2018-00389
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002534087
• UDI-Public: (01)00827002534087(17)210423(10)C1477783
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2021
• Device Model Number: G53408
• Device Catalogue Number: ECHO-HD-22-EBUS-P
• Device Lot Number: C1477783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/16/2018
• Event Location: Hospital
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1