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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

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COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE Back to Search Results
Catalog Number ECHO-HD-22-C
Device Problem Insufficient Information (3190)
Patient Problem Blood Loss (2597)
Event Date 04/09/2018
Event Type  Injury  
Manufacturer Narrative
Fcg kit, needle, biopsy - [15 abdelfatah - the diagnostic and cellularity yield of reverse. Pdf].
 
Event Description
According to the article: "title 'the diagnostic and cellularity yield of reverse bevel versus forktip fine needle biopsy - abdelfatah et al 2018. Consecutive patients with upper gastrointestinal lesions undergoing eus-fnb (endoscopic ultrasound fine needle biopsy) using 22 gauge procoretm (reverse bevel) or sharkcoretm (fork-tip) needles were included in the study. Eus-fnb was performed on all solid lesions (masses and lymph nodes) using the reverse bevel needle in consecutive patients. The study included 301 patients with a mean age of 67. 2612. 6. Of the total population, 157 patients were female, and 144 were males. Out of the 301 patients, 139 patients were in the reverse bevel needle group and 162 in the fork-tip needle group. One patient in the reverse bevel needle group developed severe bleeding requiring a blood transfusion.
 
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Brand NameECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key10198201
MDR Text Key198694006
Report Number3005580113-2020-00376
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-HD-22-C
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date06/03/2020
Event Location Hospital
Date Report to Manufacturer06/25/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/25/2020 Patient Sequence Number: 1
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