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

Catalog Number ECHO-HD-3-20-C

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

510(k) number: k142688.The investigation is still ongoing, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

After the 4th pass, the needle broke after the specimen was pushed out from the needle.The broken part was next to the side bevel.Are images of the device or procedure available? yes.If the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? patient end.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no.Please specify if yes.If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? no.If the device is a procore needle, is the device damage located at the notch / core trap? yes, if no, please specify where the damage is located.Was gaining access to the target site difficult? no.Was the device used in a tortuous position? no.Was puncture of the target site difficult? no.Please describe the anatomical location of the intended target site (pancreas if the lungs, which lymph node was being targeted? n/a.Please describe the size of the intended target site.3cm.If not with the device in question, how was the procedure performed and/or finished? was the device damaged in packaging prior to removal? no.Was the device damaged on removal from packaging? no.Was force required to remove the device? no.Did the patient require any additional procedures as a result of this event? no.What intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a.Were any other defects observed on the device prior to return (e.G.Kinks, bends, breaks etc.)? n/a, no.If yes, please specify what was observed and where on the device it was observed.What is the scope manufacturer and model number that was used? olympus , gf-uct260.Was resistance felt while inserting the device through the scope? no.Was the scope recently serviced / repaired? no.When was the issued with the product noted? after the procedure is finished, when the specimen was expelled out from the needle to the formalin container.Was the syringe used during the procedure, after the stylet was removed? yes.Was difficulty experienced while retracting the needle? no.Was it possible to fully retract the needle into the sheath before removing the device from the patient? yes.Was the endoscope in a flexed or twisted position at any time during the procedure? no.Was the stylet partially removed when advancing the needle into the target site? no.How many samples were obtained (passes completed) with this needle? 4.Did any section of the device detach inside the patient? no.If yes, please specify: was there difficulty locking the sheath (or needle) in place or slipping experienced during use? no.Was there difficulty in attaching or detaching the device to the accessory channel port on the scope? no.When the needle tip was advanced into the target site was the distal scope position adjusted so as to strain or flex the needle? no.If an ebus procedure did the needle tip hit the cartilage rings of the trachea? n/a.

Event Description

The investigation was concluded on the (b)(6) 2021, this supplement report is being submitted to include the investigation conclusions within section h.

Manufacturer Narrative

510(k) number: k142688.Complaint device was not returned therefore a document based review will be performed.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 manufacturing records for echo-hd-3-20-c of lot number c1733586 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 c1733586.The notes section of the instructions for use, ifu0077-4, 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 (ifu0077-4).A definitive root cause for the customer complaint could not be determined from the available information.A possible root cause could be attributed to the distal part of the needle breaking due to device handling when the needle was outside the patient during the process of removing the specimen after the fourth pass.It is likely needle became damaged while expelling fourth sample and therefore broke off (when the specimen was expelled out from the needle to the formalin container per additional questions).Complaint is confirmed based on customers testimony and image provided.According to the initial reporter, the patient did experience any adverse effects due to this occurrence.The needle broke after the specimen was pushed out from the needle outside the patient.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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 Key: 11021111
• MDR Text Key: 269643072
• Report Number: 3001845648-2020-00960
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002347851
• UDI-Public: (01)10827002347851(17)230529(10)C1733586
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2023
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1733586
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2020
• Event Location: Hospital
• Date Manufacturer Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1