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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
Catalog Number ECHO-HD-3-20-C
Device Problems Fracture (1260); Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2022
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
As per originally reported in (b)(4) ¿ ¿the physician did 2 sessions successfully. However, at the 3rd puncture, he recognized that something was wrong with the sheath. The sheath and needle disconnected from patient end to luer lock part. So he used another procore 20, but 2nd needle happened again. Finally he finished the case with 2 core samples. ¿ the 2nd complaint device was returned and evaluated in the lab on 04-mar-2022-- visual inspection: needle returned with distal end of needle exposed. Slight damage observed on sheath just below the sheath extender. Functional inspection: sheath extender able to advance and retract with slight difficulty. Needle able to advance with no issue but unable to retract. Needle removed from the device and proximal needle break observed just below the sheath extender. Did any section of the device remain inside the patient body? no. Did the patient require any additional procedures due to this occurrence? no. Did the product cause or contribute to the need for additional procedure(s)? no. Were there any adverse effects on the patient due to this occurrence? no. Did the product cause or contribute to the adverse effect(s)? no.
 
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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
sinead o'leary
o halloran road
national technology park
limerick 
MDR Report Key13974453
MDR Text Key298135988
Report Number3001845648-2022-00194
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 Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-HD-3-20-C
Device Lot NumberC1879548
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/11/2022
Event Location Hospital
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2021
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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