• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Catalog Number ECHO-25
Device Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2018
Event Type  malfunction  
Manufacturer Narrative
The exact customer cannot be confirmed, potential customers are as follows: (b)(6) investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
A multicenter randomized trial comparing a 25-gauge eus fine-needle aspiration device with a 20-gauge eus fine-needle biopsy device - van riet et al 2018. We set up a multicenter randomized controlled trial to compare the performance and diagnostic accuracy of a newly designed flexible 20-gauge fnb needle with a forward-facing bevel with a more conventional 25-gauge fna needle with a standard bevel, which is widely used among endosonographers because of its flexibility and proven optimal diameter for fna a total of 608 patients were allocated to fna (n z 306) or fnb (n z 302); 312 pancreatic lesions (51%), 147 lymph nodes (24%), and 149 other lesions (25%). Patients were randomized 1:1 using an online randomization. Tool accessible on site to tissue sampling with the 20-gauge procore fnb needle (fig. 1) or the 25-gauge echotip ultra fna needle (both cook medical, (b)(4)). Complaint received from internal personnel via e-mail on 29jun2020--did 30jun2020. As reported to customer relations: "for samples obtained with echo-25. The stylet was in place for 136 samples. The stylet was removed after needle insertion in 39 samples. Prior to puncture of echo-25, stylet should be retracted slightly (approximately 1 cm) from the luer fitting on the needle handle, to ensure the sharpened needle tip is exposed. This is because echo-25 the stylet extends beyond the tip of the needle. This file is being created to capture user error of stylet in place on insertion into lesion.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameECHOTIP ULTRA ENDOSCOPIC ULTRASOUND 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 Key10217550
MDR Text Key244802434
Report Number3001845648-2020-00382
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-25
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/11/2018
Event Location Hospital
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-