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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 G55738
Device Problem Wrinkled (2614)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2017
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) # k142688. (b)(4). One x echo-hd-25-c was returned to cirl for evaluation. On evaluation of the returned device, it was noted that no syringe was returned with the device. The stylet was partially inserted on return. There was no needle exposure from the sheath. There was a slight resistance when advancing the needle. There was no damage noticed to the outside of the device. There was resistance when re-inserting the stylet. The needle was crumpled- this was the reason for the resistance when re-inserting the stylet. Crumpling was within the handle. The stylet inserts distally with no resistance. The crumpling occurred 5cm from the base of the hub. The customer complaint was confirmed as the handle was crumpled. A definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting, possible causes may be due to handling of the device or possibly use of excessive force. Prior to distribution, all echo-hd-25-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 (b)(4). The notes section of the instructions for use instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper working condition, do not use". From the information provided, no adverse effects to the patient have been reported as a result of this occurrence. Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
The user punctured the pancreas head using echotip procore high definition ultrasound biopsy needle through the descending part of the duodenum. Resistance was met but he stroked several times. Then he detached the device from the endoscope and attempted to insert the stylet to collect the specimens. However the stylet would not advance any further than the middle of the device. He replaced it with another device to complete the procedure. The device was evaluated o the 23 jun 17 and the needle was confirmed to be crumpled in the handle.
 
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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 Contact
michael galvin
o halloran road
national technology park
limerick 
061334440
MDR Report Key6727900
MDR Text Key80765174
Report Number3001845648-2017-00295
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
Report Date 06/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG55738
Device Catalogue NumberECHO-HD-25-C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/20/2017
Event Location Hospital
Date Manufacturer Received06/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2016
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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