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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY
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COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY Back to Search Results
Model Number G34785
Device Problem Kinked (1339)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2018
Event Type  malfunction  
Manufacturer Narrative
The 510(k) number: k142688.(b)(4).Investigation is still pending, a follow report will be submitted to include the investigation conclusions.
 
Event Description
Advance and retrieve was difficult at desired lesion location during the first attempt of biopsy.Operator retrieved the device from endoscope and checked the tip of the needle, found out there is a kink at side slot.
 
Manufacturer Narrative
510(k) number: k142688.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending, a follow report will be submitted to include the investigation conclusions.
 
Event Description
Advance and retrieve was difficult at desired lesion location during the first attempt of biopsy.Operator retrieved the device from endoscope and checked the tip of the needle, found out there is a kink at side slot.
 
Event Description
This report is being submitted to cancel the initial mdr report.Advance and retrieve was difficult at desired lesion location during the first attempt of biopsy.Operator retrieve the device from endoscopy and check the tip of the needle found out there is a kink at side slot.Additional information received to confirm the needle was fully retracted prior to patient removal.
 
Manufacturer Narrative
510(k) number: k142688.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), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).This follow up report is being submitted as a cancellation report.In line with (b)(4): 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-hd-xx-c 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.
 
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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 Key7472136
MDR Text Key107589321
Report Number3001845648-2018-00195
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00827002347854
UDI-Public(01)00827002347854(17)200823(10)C1391867
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 04/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/23/2020
Device Model NumberG34785
Device Catalogue NumberECHO-HD-3-20-C
Device Lot NumberC1391867
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/30/2018
Event Location Hospital
Date Manufacturer Received04/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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