• 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-1-22
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Biliary Cirrhosis (1736)
Event Date 06/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Facciorusso 2019 - cirrhosis is a predictor of adverse events in endoscopic ultrasound fine-needle aspiration: a propensity-score analysis. Procedure: under sedation with propofol (diprivan¿, astrazeneca, london, uk), eus was conducted with a pentax fg-36ua ultrasound endoscope (pentax europe, ltd. , hamburg, germany) using a curved-array transducer. Once into the stomach, the eus probe was located in contact with the gastric wall and the aorta was identified in an elongated cross section and such a finding was confirmed by color doppler imaging. The scope was then slowly advanced up to duodenum when necessary. A 22 g needle (echo- tip ultra, cook medical inc. , bloomington, in, usa) with a central stylet to protect the aspiration channel of the needle was introduced though the endoscopes working channel. Directly after inserting the needle into the lesion, the stylet was removed. More than 10 to-and-fro movements were made within the solid lesion and aspiration was obtained with a 10 cm3 vacuum suction syringe applied to the hub of fna device. All cystic lesions were aspirated to complete evacuation with a single pass whenever possible, whereas solid masses were targeted with the needle and samples were fixed in 95% ethanol solution and prepared for cytological examination with papanicolaou staining. 4 serious infections: 4 cirrhotic patients experiencing serious infections - 3 were cp c stage and 1 cp b stage all serious infections experienced by cirrhotic patients led to the occurrence of aclf. Patients who experienced aclf were hospitalized and treated with intensive systemic iv broad-spectrum antibiotics, high doses of iv albumin and diuretics. 2 of the 4 patients who developed aclf died within 1 month from the procedure, whereas the other 2 patients recovered but experienced deep worsening of liver function with respect to the baseline capturing 2 patient deaths - 2 of the 4 patients who developed aclf died within 1 month from the procedure.
 
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 Key11736773
MDR Text Key247669042
Report Number3001845648-2021-00349
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeIT
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 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberECHO-1-22
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/18/2019
Event Location Hospital
Date Manufacturer Received03/30/2021
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

Patient Treatment Data
Date Received: 04/28/2021 Patient Sequence Number: 1
-
-