MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number G53408

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.Number: k160229.

Event Description

The tip of the needle got kink when trying to take sample from the suspected lesion.The case was completed with the help of cook's another ebus needle.

Event Description

This follow up report is being submitted as a cancellation report.In line with iso14971: 2012, updates were made to cirls risk management system in november 2017.These updates included the requirement to identify the initial probability of occurrence and the individual risk levels associated with each hazard and hazardous situation.As a result of the system updates the risk documentation has been revised.The severity associated with the hazardous situation has not changed however the identified risk levels associated with distal and proximal needle kinks on echo ebus devices have reduced, and are now identified as presenting a low risk to the patient or end-user.A malfunction precedence does not exist for this failure mode and no serious injury occurred - does not meet the criteria of a malfunction report.The tip of the needle got kink when trying to take sample from the suspected lesion.The case was completed with the help of cook's another ebus needle.

Manufacturer Narrative

510(k) number: k160229.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).This follow up vigilance report is being submitted as a cancellation report.In line with iso14971: 2012, updates were made to cirls risk management system in november 2017.These updates included the requirement to identify the initial probability of occurrence and the individual risk levels associated with each hazard and hazardous situation.As a result of the system updates the risk documentation has been revised.The severity associated with the hazardous situation has not changed however the identified risk levels associated with distal and proximal needle kinks on echo ebus devices have reduced, and are now identified as presenting a low risk to the patient or end-user.This event has been re-assessed and this report is to notify the fda that this event no longer meets the fda reporting criteria of a malfunction report.No adverse effects to the patient was reported as occurring.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7406889
• MDR Text Key: 105291329
• Report Number: 3001845648-2018-00167
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002534087
• UDI-Public: (01)00827002534087(17)200419(10)C1348559
• 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: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G53408
• Device Catalogue Number: ECHO-HD-22-EBUS-P
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/09/2018
• Event Location: Hospital
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 68