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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2019
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k)# k142688. Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Prior to patient contact, the user found a needle or sheath bend of echo-hd-3-20-c/lot c1637646. Another echo-hd-3-20-c was used instead. 02dec2019, (b)(6). After the first biopsy, the user removed the device from the body. When the user inserted the stylet from the hub, he felt resistance. He continued to inserting the stylet and the needle came out from the sheath tip even though the handle was locked. Therefore another echo-hd-3-20-c instead and the procedure was completed. 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
Manufacturer (Section G)
COOK IRELAND LTD
o halloran road
national technology park
limerick
Manufacturer Contact
heather ryan
o halloran road
national technology park
limerick 
MDR Report Key9516342
MDR Text Key219763194
Report Number3001845648-2019-00772
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/06/2022
Device Model NumberG34785
Device Catalogue NumberECHO-HD-3-20-C
Device Lot NumberC1637646
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/08/2019
Event Location Hospital
Date Manufacturer Received11/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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