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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-22-C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Date 03/20/2012
Event Type  Injury  
Manufacturer Narrative
Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions. As exact rpn is unknown then this is the list of potential 510 k #¿s: k160229 or k142688. Please note, due to limited information provided in this literature, we cannot confirm of the echo devices used, which of the following caused the mild acute pancreatitis , the following is a list of potential rpn¿s: 22 g fnb needle (echotip pro core) could include: echo-hd-22-ebus-o - c or echo-hd-22-c. As per 'medical device reporting for manufacturer¿s (2016), section 4. 16. 2 'submit an individual report for each device identified if the generic names of the devices are different. ' therefore, one report will be submitted in relation to the above serious injury.
 
Event Description
As reported to customer relations via literature article: title of literature review: 'randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for eus-guided sampling of solid pancreatic mass lesions' bang et al 2012. 'only 2 patients in the entire cohort had complications: 1 patient (3. 6%) in the fna group had postprocedural abdominal pain that was managed conservatively on an outpatient basis, and 1 patient (3. 6%) in the fnb cohort developed mild acute pancreatitis that required hospitalization for 2 days'. This file is created to capture 1 patient (3. 6%) in the fnb cohort developed mild acute pancreatitis that required hospitalization for 2 days'. Please note, due to limited information provided in this literature, we cannot confirm of the echo devices used, which of the following caused the mild acute pancreatitis , the following is a list of potential rpn¿s: 22 g fnb needle (echotip pro core) could include: itf052-en ebus needles: echo-hd-22-ebus-o - c or itf039-an aspiration needles: echo-hd-22-c. As per 'medical device reporting for manufacturer¿s (2016), section 4. 16. 2 'submit an individual report for each device identified if the generic names of the devices are different. ' therefore, one report will be submitted in relation to the above serious injury.
 
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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 
MDR Report Key9932679
MDR Text Key196988630
Report Number3001845648-2020-00236
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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? No
Distributor Facility Aware Date03/20/2012
Event Location Hospital
Date Manufacturer Received03/26/2020
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: 04/07/2020 Patient Sequence Number: 1
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