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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 UNKNOWN
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Hemorrhage/Bleeding (1888); Gastrointestinal Hemorrhage (4476)
Event Date 01/12/2019
Event Type  Injury  
Manufacturer Narrative
510(k) number is: k142688. Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Chon et al. 2019- ¿endoscopic ultrasound-guided liver biopsy using a core needle for hepatic solid mass¿. This study aimed to evaluate the feasibility and efficacy of endoscopic ultrasound-guided fine needle biopsy (eusfnb) using a core needle for hepatic solid masses (hsms). Additionally, the study aimed to assess factors that influence the diagnostic accuracy of eus-fnb for hsms. Retrospective analysis of patients who underwent eus-fnb for the pathological diagnosis of hsms was conducted between january 2013 and july 2017. Fifty-eight patients underwent eus-fnb for the pathologic evaluation of hsms. After evaluation, the mass was punctured using a 20-g, 22-g or 25-g core needle (echotip procore® hd ultrasound biopsy needle; wilson-cook medical inc. , bloomington, in, usa). The needles used were 20-g (n
=
14), 22-g (n
=
29), or 25-g core needle (n
=
15). Procedure-related complications occurred in only one case of hemorrhaging (1. 7%), which was successfully managed by endoscopic hemostasis. The exact rpn cannot be confirmed this file is capturing 20g, 22g or 25g echotip procore_ hd ultrasound biopsy needles.
 
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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
aisling hassett
o halloran road
national technology park
limerick 
MDR Report Key10211536
MDR Text Key202944577
Report Number3001845648-2020-00376
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeKR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
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 Date01/12/2019
Event Location Hospital
Date Manufacturer Received06/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/30/2020 Patient Sequence Number: 1
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