• 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 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 FCG KIT, NEEDLE, BIOPSY Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Date 03/06/2013
Event Type  Injury  
Manufacturer Narrative
Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions. As exact rpn is unknown then this is the list of potential 510 k #¿s: k160229 or k083330. Please note, due to limited information provided in this literature, we cannot confirm of the echo devices used, which of the following caused the 1 case of pancreatitis, the following is a list of potential rpn¿s: echo-hd-25-ebus-o (k160229) or echo-25 (k083330). As per 'medical device reporting for manufacturer's (2016), section 4. 16. 2 'submit an individual report for each device identified if the generic names of the devices are different. ' therefore, one report will be submitted in relation to the above serious injury.
 
Event Description
Title: a prospective, randomized trial comparing 25-gauge and 22-gauge needles for endoscopic ultrasound-guided fine needle aspiration of pancreatic masses - lee et al 2013. Aim: in this randomized trial, the authors tried to compare prospectively 25g and 22g in diagnostic accuracy, manipulability from the operators viewpoints and procedure related complications. According to the results, the overall complication developed in13 (6. 9%) out of 188 patients and the rate was somewhat higher than those reported in previous studies. Table v. Shows these 3 complications that occured in the 25g echotip group- 1 of which was pancreatitis and 2 of which were bleeding. This file is created to capture 1 cases of pancreatitis. Please note, due to limited information provided in this literature, we cannot confirm of the echo devices used, which of the following caused the 1 case of pancreatitis, the following is a list of potential rpn¿s: echo-hd-25-ebus-o or echo-25. As per 'medical device reporting for manufacturer's (2016), section 4. 16. 2 'submit an individual report for each device identified if the generic names of the devices are different. ' therefore, one report will be submitted in relation to the above serious injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9930966
MDR Text Key196568500
Report Number3001845648-2020-00217
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 literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/06/2013
Event Location Hospital
Date Manufacturer Received03/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/06/2020 Patient Sequence Number: 1
-
-