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U.S. Department of Health and Human Services

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

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COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Catalog Number ECHO-HD-25-EBUS-O-C
Device Problems Bent (1059); Kinked (1339); No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2017
Event Type  malfunction  
Manufacturer Narrative
The 510(k) number: k160229. (b)(4). Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
As reported to customer relations: " during an ebus, endobronchial ultrasound, procedure the echotip procore endobronchial hd biopsy needle was used. The stylet once removed from needle would not go back into the needle. The physician was completed with the procedure so no additional device was needed. The specimen already in the needle was able to be removed to get a diagnosis. There was no harm to the patient. ".
 
Manufacturer Narrative
510(k) number: k160229. (b)(4). Exemption number: e2016031. Importer site contact and address: (b)(4). Importer site establishment registration number: (b)(4). This follow up mdr is being submitted to cancel the initial mdr report. A conservative assessment deemed this event reportable based on the needle kinking proximally. However, following device evaluation the bend was confirmed to not be a kink. 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. Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
This follow up mdr is being submitted to cancel the initial mdr report. As reported to customer relations: " during an ebus, endobronchial ultrasound, procedure the echotip procore endobronchial hd biopsy needle was used. The stylet once removed from needle would not go back into the needle. The physician was completed with the procedure so no additional device was needed. The specimen already in the needle was able to be removed to get a diagnosis. There was no harm to the patient. ".
 
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Brand NameECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
Type of DeviceFCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key7272850
MDR Text Key100435308
Report Number3001845648-2018-00066
Device Sequence Number1
Product Code FCG
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
Report Date 02/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-HD-25-EBUS-O-C
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/05/2017
Event Location Hospital
Date Manufacturer Received01/19/2018
Is This a Reprocessed and Reused Single-Use Device? No

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