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 Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #k142688.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Expiration date is 01-nov-2020 but the event date is (b)(6) 2020.Engineering input received 01-jun-2021, confirming the expired product would not be related to original complaint issue (pr (b)(4) - the needle would not come out to get the specimen).Therefore an additional file was required.'our testing only support the current shelf life, however there are multiple reason that can contribute to the complaint, but use one month outside the expiration date is not one of these the root causes'.

Event Description

The investigation was concluded on the 20-jul-2021, this supplement report is being submitted to include the investigation conclusions within section.

Manufacturer Narrative

Pma/510(k) #k142688.Complaint device was not returned therefore a document based review will be performed.It should be noted that this file is related to another two complaint files.Clarification was requested from cirl engineering as follows; ¿i¿m looking for your input the actual complaint relates to an issue where the needle would not come out to get the specimen.According to information provided, this device was used during procedure on the (b)(6) 2020.Upon review of the sample label attached to the work order (b)(4), the expiry date of the device is confirmed to be (b)(6) 2020.This confirms that the complaint device was used after its expiry date would you be able to determine/assess the impact on the functionality of using this device outside of its expiry date? is it possible that it would have contributed to the failure of not being able to expel the specimen?¿ reply was received as follows; ¿our testing only support the current shelf life, however there are multiple reason that can contribute to the complaint, but use one month outside the expiration date is not one of these the root causes,¿ as a result of the above an additional (b)(4) was opened for ¿use of an expired device related to (b)(4).This file investigates (b)(4) the use of an expired device.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 a review of the manufacturing records for echo-hd-22-c of lot number c1415948 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1415948.The notes section of the instructions for use, ifu0077-4, which accompanies this device instructs the user to inspect the device prior to use: "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 the user did not follow the ifu.A definitive root cause can be attributed to user error as echo devices should not be used beyond the date specified on the product label, therefore the user did not follow the instructions for use.The customer complaint can be confirmed as the device was used after its expiry date.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.

• 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: 12084150
• MDR Text Key: 258911069
• Report Number: 3001845648-2021-00525
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002557366
• UDI-Public: (01)10827002557366(17)201101(10)C1415948
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: ECHO-HD-22-C
• Device Lot Number: C1415948
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/15/2020
• Event Location: Hospital
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1