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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 01/09/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Bor et al 2019 ¿prospective comparison of slow-pull and standard suction techniques of endoscopic ultrasound-guided fine needle aspiration in the diagnosis of solid pancreatic cancer. ¿ 92 patients were enrolled who underwent eus-fna sampling due to suspected pancreatic cancer. 92 eus-fna sampling of 89 patients were involved between january 2014 and june 2016. Linear echoendoscope (olympus gf-uct 140; olympus gf-uct 160; olympus optical, (b)(4)) and 22g fna needles (echotip ultra; cook (b)(4). , (b)(4); ez shot 2, olympus optical, (b)(4)) were applied for the sampling. After the determination of the optimal puncture site, the needle was inserted under continuous real-time ultrasound guidance to the target lesion and approximately 10 to 15 back-and-forth movements were done in a fanning manner. 2¿2 punctures using sp and ss technique were proposed to be carried out with the same needle from the same lesion, but reduction or increase of the punctures¿ number was allowed if the examiner considered it necessary based on the quality of the obtained specimen. In case of sp, suction force is generated by the slow pull out of stylet during the back-and-forth movements of needle. In case of ss technique, 5ml syringe was attached to the hub of the needle after quick removal of the stylet to create greater suction force compared to sp. There was no significant difference between the use of cook medical and olympus ez shot 2 needles (47 vs. 55 cases). A (b)(6)-year old man developed mild, postprocedural acute pancreatitis, which recovered during 4-days long total parenteral nutrition.
 
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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 Key11548707
MDR Text Key256696199
Report Number3001845648-2021-00232
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeHU
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 06/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2021
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 Date01/09/2019
Event Location Hospital
Date Manufacturer Received02/22/2021
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: 03/23/2021 Patient Sequence Number: 1
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