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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 ECHO-HD-19-C
Device Problem Retraction Problem (1536)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Manufacturer Narrative
The 510(k) number: k142688. (b)(4). Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Literature complaint: comparison of eus-guided tissue acquisition using two different 19-gauge core biopsy needles: a multicenter, prospective, randomized, and blinded study. Dewitt (2015). As reported to customer relations: "all patients were followed for a minimum of 6 months. The prevalence of adverse events related to the fnb needle malfunction (1/41; 3%) was similar to tcb needle malfunction (2/37; 5%; p
=
0. 6;"). In one patient with suspected type 2 autoimmune pancreatitis undergoing fnb of the tail of the pancreas, the needle would not retract into the sheath (likely from elevator deflection of the needle into a fibrotic gland) after the first attempted biopsy. The endoscope and unretracted needle were removed together from the pancreas and out of the patient. Immediate reinsertion of the echoendoscope demonstrated retroperitoneal hemorrhage in the left upper quadrant which was confirmed by ct scan the same day. The patient had mild shoulder pain and was discharged less during biopsy of a pancreatic head mass. Pathology diagnosis from this first and only tcb pass as well as both crossover fnb biopsies demonstrated pet. ".
 
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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
heather ryan
o halloran road
national technology park
limerick 
061334440
MDR Report Key7852130
MDR Text Key119490488
Report Number3001845648-2018-00417
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 Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-HD-19-C
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 Date09/06/2018
Event Location Hospital
Date Manufacturer Received08/21/2018
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: 09/06/2018 Patient Sequence Number: 1
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