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

Model Number G34785

Device Problems Break (1069); Retraction Problem (1536)

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

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k142688.(b)(4).The following information was received: "the channel size of the scope is 3,8 mm".Complaint device was returned to cirl for evaluation.Upon evaluation of the returned device the following was noted: the device was returned in original packaging.The needle was exposed on return.The stylet was not in place on return.There was a kink in the needle.The needle was broken and was removed from the device.The customer complaint is confirmed as the needle was broken.The needle can break due to excessive force are even a possibly a torturous position during the procedure.A needle break may also be attributed to patient anatomy if the lesion being punctured was a hard lesion or if the endoscope was used in a tortuous anatomy.However, as the conditions of use cannot be replicated during the laboratory evaluation, it is not possible to conclusively state that this is the cause of this complaint.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, 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¿.According to the information received, 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

Failure of the septum for the reinsertion of the needle after first punction.It was used for a mediastinal transesophageal punction over adenopathy, another needle was used to perform the punction.Customer would like compensation for the second needle."as per complaint form": during the punction they can't remove the needle into the sheath (they think the handle was broken).They remove the device at the endoscope and they had taken another needle device.

• 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: 6879210
• MDR Text Key: 87873727
• Report Number: 3001845648-2017-00405
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)200302(10)C1332890
• 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: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/20/2017
• Event Location: Hospital
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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