MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-22-C

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Fnb case was completed without any complications.After the completion of the fnb procedure, the scope was reprocessed.During the cleaning and passing of the endoscope cleaning brush, a foreign object was located within the endoscope channel.Retrieval of the foreign object was pulled out of the tip of the endoscope.The account suspects the object came from within the needle.Both the needle and the foreign object are enclosed within package returned to cook.

Event Description

Fnb case was completed without any complications.After the completion of the fnb procedure, the scope was reprocessed.During the cleaning and passing of the endoscope cleaning brush, a foreign object was located within the endoscope channel.Retrieval of the foreign object was pulled out of the tip of the endoscope.The account suspects the object came from within the needle.Both the needle and the foreign object are enclosed within package returned to cook.

Manufacturer Narrative

510(k) number: k142688.(b)(4).Exemption number: e2016031.(b)(4).Three attempts were made for the following information; we have evaluated the device & "foreign object".There is no issues with the returned device ? they are complaining about this foreign object, however this "object" which looks to be a needle cannula does not belong to the device that they used the dimensions of the needles do not match.Was this scope flushed before use because i cant see how it got in there if it was not already present from a previous procedure or did they use a different gauge needle before they used our device? i just want to be sure that they are not complaining about the functionality of our device? however, as of 20th march 2018 there has been no reply.This complaint will be updated once this information is received.Lab evaluation: 1 x echo-hd-22-c device of lot #unknown was returned to cirl for evaluation.Upon evaluation, the device was returned in a plastic bag.The stylet was not returned.The needle advances and retracts without issue.There was a kink below the sheath extender which is likely due to the manner in which it was transported.No other functional issues were noted with the device.The needle that was returned does not belong to this device.The needle for an echo-hd-22-c has an outer diameter (od) of approx.0.75mm whereas the foreign needle that was returned measures approx.1.06mm.Root cause: a definitive root cause cannot be established for this complaint as the issue is due to a foreign needle which is not part of the complaint device.However, it is possible that this can be attributed to the cleaning of the endoscope.This complaint is not confirmed as the failure mode could not be verified in the laboratory.As the lot number is unknown, it is not possible to perform a review of the work order.Documents review: prior to distribution, all echo-hd-22-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.Ifu review: it may be noted that according to the instructions for use, ifu0077-4, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.Summary: 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.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7319710
• MDR Text Key: 102120135
• Report Number: 3001845648-2018-00111
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-22-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/12/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 02/14/2018
• Supplement Dates FDA Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR