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

Model Number G55738

Device Problem Wrinkled (2614)

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

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k142688.(b)(4).One x echo-hd-25-c was returned to cirl for evaluation.On evaluation of the returned device, it was noted that no syringe was returned with the device.The stylet was partially inserted on return.There was no needle exposure from the sheath.There was a slight resistance when advancing the needle.There was no damage noticed to the outside of the device.There was resistance when re-inserting the stylet.The needle was crumpled- this was the reason for the resistance when re-inserting the stylet.Crumpling was within the handle.The stylet inserts distally with no resistance.The crumpling occurred 5cm from the base of the hub.The customer complaint was confirmed as the handle was crumpled.A definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting, possible causes may be due to handling of the device or possibly use of excessive force.Prior to distribution, all echo-hd-25-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 (b)(4).The notes section of the instructions for use instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".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

The user punctured the pancreas head using echotip procore high definition ultrasound biopsy needle through the descending part of the duodenum.Resistance was met but he stroked several times.Then he detached the device from the endoscope and attempted to insert the stylet to collect the specimens.However the stylet would not advance any further than the middle of the device.He replaced it with another device to complete the procedure.The device was evaluated o the 23 jun 17 and the needle was confirmed to be crumpled in the handle.

• 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: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6727900
• MDR Text Key: 80765174
• Report Number: 3001845648-2017-00295
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002557383
• UDI-Public: (01)00827002557383(17)190628(10)C1246465
• Combination Product (y/n): N
• 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: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G55738
• Device Catalogue Number: ECHO-HD-25-C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/20/2017
• Event Location: Hospital
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2016
• 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