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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD FCG KIT, NEEDLE, BIOPSY

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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 05/12/2014
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 k142688. Please note, due to limited information provided in this literature, we cannot confirm of the echo devices used, which of the following caused the mild pancreatitis, the following is a list of potential rpn¿s: echo-hd-22-ebus-o ¿ c (k160229) / echo-hd-25-ebus-o ¿ c (k160229) or echo-hd-22-c (k142688) / echo-hd-25-c (k142688). 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 of literature: core biopsy needle versus standard aspiration needle for endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized parallel-group study - lee et al 2014. Study aims: we prospectively compared the diagnostic accuracy of eus-fnb with standard eus guided fine needle aspiration (eus-fna) in patients with solid pancreatic masses. One case of mild pancreatitis occurred in the fna group, which was managed conservatively with 2 days of hospitalization. This file is created to capture one case of mild 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 mild pancreatitis, the following is a list of potential rpn¿s: echo-hd-22-ebus-o / echo-hd-25-ebus-o or echo-1-22 / 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.
 
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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 Key9932670
MDR Text Key196569287
Report Number3001845648-2020-00235
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 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2020
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? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/12/2014
Event Location Hospital
Date Manufacturer Received03/23/2020
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: 04/07/2020 Patient Sequence Number: 1
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