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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-3-20-C
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/22/2019
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) # k142688.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Echo-hd-3-20-c was used for eus-fna in the pancreas.When the user attempted to push out specimen from the needle after the 2nd biopsy, the user noticed that the needle was badly bent (broken) and almost separated at the core trap.The user attempted to fix the bend with a tweezers but the needle was separated.Another needle(ez-shot iii/ olympus) was used instead and the procedure was completed.There have been no adverse effects to the patient reported.
 
Event Description
Echo-hd-3-20-c was used for eus-fna in the pancreas.When the user attempted to push out specimen from the needle after the 2nd biopsy, the user noticed that the needle was badly bent (broken) and almost separated at the core trap.The user attempted to fix the bend with a tweezers but the needle was separated.Another needle(ez-shot iii/ olympus) was used instead and the procedure was completed.There have been no adverse effects to the patient reported.
 
Manufacturer Narrative
Pma/510(k) # k142688.The echo-hd-3-20-c device of unknown lot number involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 31jul2019.There was a break at the notch area of the distal end of the needle.As the lot number of the device is unknown, a review of the relevant manufacturing records cannot be conducted.However, 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.There is no evidence to suggest that the customer did not follow the instructions for use.The failure of needle broken was observed in the laboratory.A definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to hard lesion and the device being used in a flexed or twisted position as indicated in the additional information.Complaint is confirmed as the failure was verified in the laboratory.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.
 
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Brand Name
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Type of Device
FCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key8921216
MDR Text Key219763664
Report Number3001845648-2019-00433
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
Type of Report Initial,Followup
Report Date 08/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberECHO-HD-3-20-C
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/22/2019
Event Location Hospital
Initial Date Manufacturer Received 07/26/2019
Initial Date FDA Received08/22/2019
Supplement Dates Manufacturer Received07/26/2019
Supplement Dates FDA Received09/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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