MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number	G34785
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k142688.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The needle was used to take 2 samples of a pancreatic mass as per the ifu.After the second pass the needle was removed from the scope and the nurses were trying to place the second sample into a pot.When reinserting the stylet it became apparent the needle had broken as although the safety ring was locked on 2cm the needle was protruding approx.10cm out of the end of the sheath and continued to move out as the stylet was pushed in.The device was then put aside and another procore 20 needle was used to complete the procedure.
Additional Manufacturer Narrative
Pma/510(k) # k142688.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The needle was used to take 2 samples of a pancreatic mass as per the ifu.After the second pass the needle was removed from the scope and the nurses were trying to place the second sample into a pot.When reinserting the stylet it became apparent the needle had broken as although the safety ring was locked on 2cm the needle was protruding approx.10cm out of the end of the sheath and continued to move out as the stylet was pushed in.The device was then put aside and another procore 20 needle was used to complete the procedure.
Additional Manufacturer Narrative
Pma/510(k) # k142688.The echo-hd-3-20-c device of lot number c1594386 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.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 distal kink in the notch area, leur (mlla) off centre.Proximal break below sheath extender.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 relevant manufacturing records (c1594386) revealed no discrepancies that could have contributed to this complaint.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 be excessive force during use while the scope was in a flexed position, which broke the needle.Complaint is confirmed based on the laboratory evaluation.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 or Problem Description
The needle was used to take 2 samples of a pancreatic mass as per the ifu.After the second pass the needle was removed from the scope and the nurses were trying to place the second sample into a pot.When reinserting the stylet it became apparent the needle had broken as although the safety ring was locked on 2cm the needle was protruding approx.10cm out of the end of the sheath and continued to move out as the stylet was pushed in.The device was then put aside and another procore 20 needle was used to complete the procedure.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8854193
• Report Number: 3001845648-2019-00385
• Device Sequence Number: 14010728
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)220313(10)C1594386
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2019

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
• Operator of Device: Health Professional
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1594386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/08/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/08/2019; 07/09/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 08/29/2019; 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1