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

Catalog Number ECHO-HD-3-20-C

Device Problem Retraction Problem (1536)

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

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) #k142688.The device involved in this complaint was not available for return to cook ireland for evaluation.With the information provided a document based investigation was carried out.R and d engineer confirmed that the most likely root cause for this particular issue is a kink or break to the needle either proximally or distally, however as he device was not returned for evaluation; the cause of this complaint could not be conclusively determined.The customer complaint is considered to be confirmed based on customer testimony.The manufacturing records of the device involved in this complaint (b)(4) did not reveal any discrepancies.Prior to distribution, all echo 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.The instructions for use, ifu0077-3, advises the user to ¿visually inspect with particular attention to kinks, bends or breaks.If an abnormality is detected that would prohibit proper working condition, do not use¿.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

During an endosonography biopsy, they used a biopsy needle.Once the needle was out and the liquid biopsy was done, it was impossible to put the needle back in to take the device out of the endoscope.Risk of perforation of the endoscope when pulling out the device.No clinical consequences.No return.

• 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
• Manufacturer Contact: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6489319
• MDR Text Key: 72662131
• Report Number: 3001845648-2017-00126
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)190620(10)C1241410
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2017

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-3-20-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/13/2017
• Date Device Manufactured: 06/20/2016
• 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