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

Catalog Number ECHO-HD-22-EBUS-O

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

510 k #: k160229.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

During the operation, totaly 1 needle has been used because of needle punching problem to the tissue.Whenever doctor had been try to punch, sheat had been slided into the scope.That is why doctor could not complete the case.

Manufacturer Narrative

510 k# : k160229.Device evaluation: 1 unit of lot: c1693843 of echo-hd-22-ebus-o was returned opened in its original packaging.It should be noted that this file is related to another complaint file.For details of the other investigation please refer to (b)(4).Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 01 april 2020.The tip of the needle was found to be kinked distally.Sheath extender lock area inspected, and no cracks / damage observed.Thumbscrew on extender locked and sheath extender unable to be moved.Document review including ifu review: 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.A review of the manufacturing records for echo-hd-22-ebus-o of lot number: c1693843 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has previously occurred with the current lot number.This was with (b)(4) (emdr ref#: 3001845648-2020-00199).Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number: c1693843.The notes section of the instructions for use, ifu0051-8 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" and "ensure the stylet is fully inserted when advancing the needle into the biopsy site" and "this device is intended for use with an olympus ebus scope".There is evidence to suggest that the customer did not follow the instructions for use in relation to the use of the stylet (ifu0051-8).Q.10 of the additional information also indicates that a fujifilm eb-530us scope was used rather than an olympus scope as per ifu0051-8 ¿this device is intended for use with an olympus ebus scope¿.There is evidence to suggest that the customer did not follow the instructions for use in relation to the type of scope used.Root cause review: a definitive root cause could be attributed to user error as the stylet should not be partially removed prior to advancement of the needle into intended targeted site.As the stylet provides support to the needle for puncture this would have led to the distal end of the needle to kink.Summary: complaint is confirmed as the failure was verified in the laboratory and from images provided.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 Description

During the operation, totally 1 needle has been used because of needle punching problem to the tissue.Whenever doctor had been try to punch, sheat had been slided into the scope.That is why doctor could not complete the case.A section of the device did not remain inside the patient¿s body.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.

• 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
• MDR Report Key: 9929021
• MDR Text Key: 228437226
• Report Number: 3001845648-2020-00201
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002520117
• UDI-Public: (01)10827002520117(17)221220(10)C1693843
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2022
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Device Lot Number: C1693843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/02/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1