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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 Problems Bent (1059); Kinked (1339); No Apparent Adverse Event (3189)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2017
Event Type  malfunction  
Manufacturer Narrative
510(k) number: k142688. (b)(4). Exemption number: e2016031. (b)(4) this follow up mdr is being submitted to cancel the initial mdr report. A conservative approach was taken in initially assessing the lab evaluation. After further review of the lab evaluation it can be confirmed that the needle did not kink distally. The bend at the distal end of the needle is contributed to natural procedural curvature. 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. A conservative assessment deemed this event reportable based on the needle kinking distally. However, following device evaluation the bend noted on the device is a natural procedure curvature and not a kink.
 
Manufacturer Narrative
The 510(k) number: k142688. (b)(4). Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
The device was used for eus-fna. The first device ((b)(4)): the needle was advanced from the duodenum bulb to the pancreas head. At the second attempt of biopsy, the distal luer lock could not be attached to fujifilm's endoscope properly. Therefore, the device was replaced with another echo-hd-3-20-c. The second device ((b)(4)): biopsy was continued with the second device though, the distal luer lock could not be attached to the endoscope properly. Therefore, olympus's device was used instead to complete the procedure. There have been no adverse effects to the patient reported.
 
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Brand NameECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Type of DeviceFCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key7250811
MDR Text Key286647099
Report Number3001845648-2018-00047
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 02/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG34785
Device Catalogue NumberECHO-HD-3-20-C
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/06/2018
Event Location Hospital
Date Manufacturer Received01/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

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