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

Model Number	G34785
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Fnb procedure was being performed with echo-hd-3-20-c.4 sessions were finished.However, at the 4th time of finishing, the assistant nurse recognized that the tip of the needle was broken.The physician examined by ct and x-ray, he found that the needle tip was broken and remained in the pancreatic mass.Further endoscopic procedure will be performed within this week.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Device evaluation 1 unit of lot number c2269975 of echo-hd-3-20-c was returned for evaluation, open in its original packaging.The device related to this occurrence underwent a laboratory evaluation on the 10th of september 2025 and lab re-evaluation on the 23rd of september.On evaluation of the devices the following observations were made: visual inspection: device returned without stylet, kink below sheath extender observed, mlla observed to be off centre, distal end of needle examined and observed to be broken.Functional inspection: sheath extender able to retract fully but would not advance past kink below sheath extender., needle handle able to advance but when handle retracted the needle did not retract into the sheath, needle removed from device and break observed below sheath extender.Lab re-evaluation visual inspection: break on the distal end of the needle is located after the dimples.Remaining section of distal end of needle observed to be slightly kinked.The reported failure was observed.An image was provided to support the complaint investigation which shows the needle with a broken tip, exposed needle appears to be slightly kinked.Clarification was requested as follows: ¿during lab evaluation proximal needle break and mlla off centre was observed (please see picture below).As per answers to additional questions, the customer states that there was no other defects (other than the complaint issue) observed on the delivery system.This could occur during transport/return process.Could you please confirm with the customer if the proximal break and mlla off centre was observed prior to return to cirl.¿ response was provided as follows: ¿maybe it was possible that the luer lock part kinking.But the main reason of this case was tip breakage.So the physician and nurse didn¿t mention other defects except tip breakage.¿ manufacturing records prior to distribution, all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records for echo-hd-3-20-c of lot number c2269975 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the ¿notes¿ section of the instructions for use, ifu0077 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 image review an image was not returned for evaluation.Root cause analysis a definitive cause could not be determined from the investigation.A possible root cause was determined and could be attributed to advancement into a hard lesion.From additional information provided it is known that the puncture of the target site was difficult, it was also noted that ¿the mass was solid¿.After obtaining four core tissues, the needle tip broke during the last puncture attempt, potentially due to the hardness of the lesion, subsequently, needle break may have caused a build-up of pressure resulting in the distal end of needle to kink.Issues observed during lab evaluation, specifically the proximal break and mlla off-center, have likely occurred during the transport or return process to cirl, from additional information provided ¿the physician and nurse didn¿t mention other defects except tip breakage¿.Confirmation of complaint complaint is confirmed based on visual and/or functional inspection.Corrective action/correction complaints of this nature will continue to be monitored for similar events.Summary of investigation according to the customer, the tip of the needle was broken.Confirmed quantity, 01 device was confirmed used.According to the initial reporter, the physician examined by ct and x-ray, he found that the needle tip was broken and remained in the pancreatic mass.Further information was provided: ¿the hospital planned an additional procedure to remove the broken needle tip.The case was registered under complaint no.Cn-087903 and was also scheduled to be reported to the mfds as an adverse event.However, today the hospital informed us that the broken needle tip appears to have been removed during the process of extracting a stent that had been previously inserted into the patient's gastrointestinal tract.Please note that this is not 100% confirmed, and if the needle tip is found again in the future, another removal procedure may be necessary.¿ as per medical advisor input ¿from clinical perspective, the structures in the retroperitoneum i.E., the head and body of the pancreas tend not to move much, so there is a low possibility that the retained broken needle will cause any future issues.Inflammation might/might not occur and would unlikely cause harm to patient.¿ investigation findings conclude that a definitive root cause could not be determined.A possible root cause was determined and could be attributed to advancement into a hard lesion.From additional information provided it is known that the puncture of the target site was difficult, it was also noted that ¿the mass was solid¿.After obtaining four core tissues, the needle tip broke during the last puncture attempt, potentially due to the hardness of the lesion, subsequently, needle break may have caused a build-up of pressure resulting in the distal end of needle to kink.Complaints of this nature will continue to be monitored for similar events.Complaint is confirmed based on visual and/or functional inspection.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 24 sep 2025.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Common Device Name: FCG,BIOPSY NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; national technology park; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 22873203
• Report Number: 3001845648-2025-00423
• Device Sequence Number: 10424408
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)280221(10)C2269975
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K210476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2025
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C2269975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/29/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown