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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 Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2019
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) #k142688. Complaint device was not returned therefore a document based review will be performed. Prior to distribution, all echo-hd-3-20-c devices are subjected to functional checks and visual inspection to ensure device integrity. These inspections and functional checks are outlined in internal procedures in place at cirl. A review of the manufacturing records for echo-hd-3-20-c of lot number c1640405 did not reveal any discrepancies that could have contributed to this complaint issue. The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number. Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1640405. The notes section of the instructions for use, which accompanies this device instructs the user to inspect the device prior to use : "visually inspect with particular attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper working condition, do not use". There is no evidence to suggest that the customer did not follow the instructions for use. A definitive root cause could not be determined from the available information. A possible root cause could be attributed to a possible kink that occurred during handling of the device during sample collection. Complaint is confirmed based on the customers testimony. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
Patient was having an eus procedure to sample a pancreatic mass. The needle was used as per the ifu. After the fourth pass the device was removed from the scope and the needle extended from the sheath to collect the sample. The sample was collected. The nurse attempted to resheath the needle and it would not retract. As the procedure was already finished at this point the device was disposed of.
 
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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 Key9394579
MDR Text Key219772212
Report Number3001845648-2019-00655
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00827002347854
UDI-Public(01)00827002347854(17)220813(10)C1640405
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
Report Date 11/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/13/2022
Device Model NumberG34785
Device Catalogue NumberECHO-HD-3-20-C
Device Lot NumberC1640405
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/04/2019
Event Location Hospital
Date Manufacturer Received11/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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