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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY

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COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Catalog Number ECHO-1-22
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pancreatitis (4481)
Event Date 10/25/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Facciorusso et al 2020 ¿ statins decrease the risk of acute pancreatitis after endoscopic ultrasound fine-needle aspiration of pancreatic cysts¿ we reviewed data of our series of 456 patients with sus- pected pcls evaluated by means of eus between january 2006 and july 2018. Emptying of the cyst was performed through a 22 g needle (echotip ultra, cook medical inc. , bloomington, indi- ana, usa) with a central stylet (immediately removed after the procedure). A transduodenal approach was adopted in the case of pcls of the pancreatic head and uncinate process, while the trans- gastric approach was used for pcls of the body or tail. Median age was 64 years (iqr, 62¿69) and most patients were male (58. 9%), without difference between groups. 3 patients in the control group were classified as severe pancreatitis. Patients with serious abdominal pain were hospitalized, treated with analgesics and antibiotics, and underwent ct-scan to assess the severity of ap. In univariate logistic regression analysis, previous history of pancreatitis, cyst histology, and non-use of statins were predictors of ap incidence.
 
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Brand NameECHOTIP ULTRA ENDOSCOPIC ULTRASOUND 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 
MDR Report Key11730885
MDR Text Key263924520
Report Number3001845648-2021-00342
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K083330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberECHO-1-22
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 Date10/25/2019
Event Location Hospital
Date Manufacturer Received03/30/2021
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: 04/27/2021 Patient Sequence Number: 1
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