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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
Model Number G31520
Device Problems Break (1069); Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/10/2019
Event Type  malfunction  
Manufacturer Narrative
Complaint device was not returned therefore a document based review will be performed. Images were shared of the complaint device. Based on the complaint description, answers to the additional questions and the images provided the most likely outcome is that the needle broke proximally during the procedure which in turn contributed to the sheath damage evident in the images. As the needle was not able to move forward or backward this would indicate that the needle was broken. Prior to distribution, all echo-19 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-19 of lot number c1596846 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 c1596846. The notes section of the instructions for use, which accompanies this device instructs the user to; "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 excessive force which can lead to needle and sheath damage. Complaint is confirmed based on the customer's 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
On (b)(6) 2019 the patient underwent puncture echoendoscope due to oesophageal sub epithelial lesion. The echo needle was introduced through the working channel of the device and exposed to the sheath positioned for the echo guided puncture, and when the needle was inserted into the lesion, a click was heard and the needle did not progress properly. An attempt was made to retract the needle into the sheath without success. The needle was removed and another one with the same specifications was used to complete the procedure uneventfully. After examination, the needle was examined and it was found that the sheath had broken in its proximal portion and that the movements of the needle handle did not move it forward or backward.
 
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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 Key9368352
MDR Text Key220540295
Report Number3001845648-2019-00623
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00827002315204
UDI-Public(01)00827002315204(17)220321(10)C1596846
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
Report Date 10/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/21/2022
Device Model NumberG31520
Device Catalogue NumberECHO-19
Device Lot NumberC1596846
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/10/2019
Event Location Hospital
Date Manufacturer Received10/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2019
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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