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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
Model Number G34785
Device Problem Break (1069)
Patient Problem Needle Stick/Puncture (2462)
Event Date 07/08/2019
Event Type  Injury  
Manufacturer Narrative
Pma/510(k) # k142688. Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
The needle was used to take 2 samples of a pancreatic mass as per the ifu. On the third pass with the procore 20 needle the pancreatic mass was punctured and then the stylet was removed. When the doctor began to pull back slightly on the needle to commence fanning he felt no resistance and noted the needle was not moving on the ultrasound image (269656). He immediately removed the scope from the patient and when the scope was withdrawn the shaft of the needle was still protruding from the patients mouth. A nurse grabbed the needle shaft and pulled it out of the patient. As the end of the needle came out of the patients mouth the nurse suffered a needle stick injury to the arm from the end of the needle (271124). The procedure was completed with another procore 20 needle. There were no reported adverse events to the patient. The nurse underwent needle stick injury protocol.
 
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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 Key8854320
MDR Text Key153081335
Report Number3001845648-2019-00391
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/13/2022
Device Model NumberG34785
Device Catalogue NumberECHO-HD-3-20-C
Device Lot NumberC1594386
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/08/2019
Event Location Hospital
Date Manufacturer Received07/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2019
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: 08/02/2019 Patient Sequence Number: 1
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