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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pancreatitis (4481)
Event Date 04/06/2020
Event Type  Injury  
Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions. Pma/510(k) #: k160229/k142688.
 
Event Description
Kovacevic et al 2020 - eus tissue acquisition: from a to b (review article). This review article does not provide any specific information in relation to patients, procedures or devices use. Overall adverse effects were referenced as below for fnb / procore needles: eus ta is an established and safe procedure with an overall risk of adverse events as low as 0. 29%. Hemorrhage (0. 15%¿3. 7%) - observed hemorrhage is in most cases self limiting, and eus ta can be safely performed even in patients treated with aspirin and nonsteroidal anti inflammatory drugs. However, p2y12 receptor antagonists and oral anticoagulants should be discontinued prior to eus ta in order to minimize the risk of hemorrhage. Acute pancreatitis (0. 29%¿2. 0%). Infection (0. 4%¿3. 9%) - risk of infection is considered generally low when performing eus ta of solid lesions, even in transrectal and/or transcolonic approach, and current guidelines do not recommend routine prophylactic antibiotic treatment when biopsy of solid lesions is performed. In case of cystic lesions, however, the risk of infection is higher, and administration of prophylactic antibiotics is recommended.
 
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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
sinead o'leary
o halloran road
national technology park
limerick 
MDR Report Key13024303
MDR Text Key283976719
Report Number3001845648-2021-00875
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
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 Date04/06/2020
Event Location Hospital
Date Manufacturer Received11/25/2021
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: 12/17/2021 Patient Sequence Number: 1
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