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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-19-C
Device Problems No Apparent Adverse Event (3189); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions. Pma/510(k) #: k142688.
 
Event Description
All of incidents had occured in cases of eus- biopsy of focal lesions in the pancreatic head. I would classify all of the cases as a routing eus-fnb procedure. We had not been able to pull back the tip of the needle into the sheath. While we had been trying to safely remove the damaged needle and the endoscope from the patient, it caused damage to the channel of the echoendoscope. Damage on two occasions leading to very expensive repair and impairment of our eus service. Patient outcome: a section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence additional questions: if the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? distal end. Please describe the location in the body for the intended target site (pancreas, stomach, lungs etc. ). Pancreas. If the lungs, which lymph node was being targeted? e. G. 2r, 2l, 4r, ao, ar, 11ri, 11s etc. Please describe the size of the intended target site. 3 cm. If not with the device in question, how was the procedure performed and/or finished? procedure was finished with needle of other company. Was the device used in a tortuous position? device was used from duodenal position. Are images of the device or procedure available? images of the device is available. Was the device damaged in packaging before removal? no. Was the device damaged on removal from packaging? no. Was force required to remove the device? no. For complaints occurring during use (once in contact with endoscope) also ask: what is the endoscope manufacturer and model number that was used? olympus- this scope was damaged beyond repair. Was the scope recently serviced / repaired? not. Was resistance felt while inserting the device through the scope? no. When was the issued noted? e. G. On advancement of the sheath/needle or on needle retraction? was the syringe used during the procedure, after the stylet was removed? the syringe was used. Was difficulty experienced while retracting the needle? yes. Was it possible to fully retract before removing the needle from the patient? no. Was gaining access to the target site difficult? no. Was the endoscope in a flexed or twisted position at any time during the procedure? it was standard duodenal position. Was puncture of the target site difficult? no. Was the stylet partially removed when advancing into the target site? no. How many samples were obtained with this needle? none. Did any section of the device detach inside the patient? no. If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? no. Was there difficulty locking the sheath (or needle) in place or slipping experienced during use? no. Was there difficulty in attaching or detaching the device of the luer lock to the scope? no. If the device is a procore, is the kink located distally at the notch / core trap? rather not, but the needle was sent, please rate.
 
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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
aisling hassett
o halloran road
national technology park
limerick 
MDR Report Key12376567
MDR Text Key268474706
Report Number3001845648-2021-00627
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2021
Device Catalogue NumberECHO-HD-19-C
Device Lot NumberC1448955
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/09/2021
Event Location Hospital
Date Manufacturer Received07/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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