MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number	NA-U200H-8019
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a pancreatic cyst drainage, the device did not come out of the sheath.Due to this malfunction, the procedure was aborted and is scheduled to be completed 8aug2024.The patient was under general anesthesia.There were no health problems for the patient other than the postponement of the procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's (lm) investigation.The device was evaluated by olympus, and the following was observed: the insertion part was buckled near the base and at a position 650 mm from the tip.During disassembly of the device, it was noted that part of the internal part of the sheath tip (a part that prevents the needle from piercing the coil sheath) was deformed and cracked.When this part was viewed from the control part side, it was found to be preventing the needle from being inserted.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, it was determined that the surgical procedure delay was caused by the needle¿s inability to extend from the sheath.Moreover, it is possible that damage to the internal parts of the device occurred through the following mechanism: 1) the needle was pulled out while the forceps elevator was in the up position.2) the coil sheath was fixed by the forceps elevator, so the aspiration biopsy needle could not be pulled out and the coil sheath extended, causing the needle tube to shift towards the hand.3) the needle tube got caught on the end face of a part inside the sheath.4) when an attempt was made to eject the needle tube, the tip scraped the internal part, damaging it.5) damage to the internal part made it impossible to eject the needle.The deformation and buckling of the insertion part was likely caused by a bending load applied while connecting or removing it from the endoscope.However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which states: ¿when straightening the insertion tube from a curled state, do so slowly with both hands.If you do it suddenly, its elasticity may cause the entire insertion tube to bounce, which may result in injury to the human body from the needle tip or stylet tip, or damage to the device or a decrease in its functionality.¿ ¿do not roll the insertion tube into a diameter smaller than 20 cm.This may cause damage to the insertion tube.¿ ¿do not bend, pull or compress the product excessively, as this may result in damage to the device or a decrease in its functionality.¿ ¿do not use this product if the insertion part is broken, bent, cracked, or deformed.Using a product with a deformed insertion part may lead to unexpected perforation, heavy bleeding, or mucosal damage.¿ ¿if there is strong resistance making it difficult to insert the suction biopsy needle into the endoscope, do not force it in.Return the angle of the endoscope to the point where it can be inserted without difficulty.If there is strong resistance making insertion difficult even after returning the angle of the endoscope, discontinue use.Forcing the needle into the endoscope may result in perforation, heavy bleeding, mucosal damage, or damage to the endoscope or suction biopsy needle.¿ ¿if there is a strong resistance making it difficult to insert the endoscope, do not forcefully push the sheath adjuster in.Return the angle of the endoscope to the point where it can be inserted without difficulty.If there is still a strong resistance making insertion difficult even after returning the angle of the endoscope, discontinue use.Forcing the sheath adjuster in may cause the tip of the sheath to suddenly protrude from the tip of the endoscope, which may result in perforation, heavy bleeding, mucosal damage, or damage to the endoscope or aspiration biopsy needle.¿ ¿when removing the product from the tray, do not remove it from the sheath.The sheath may bend at the tip of the handle, which may result in damage to the product.¿ this supplemental report includes a correction to b5 and g2 to provide information that was inadvertently not included in the initial medwatch.Also, an update has been made to b5, d4, d9, and h3.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the issue occurred during the first attempt to insert the needle.Moreover, the procedure was reportedly aborted and treatment postponed because the facility did not have a replacement device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to h6 (type of investigation) from the previous submission."4114" has been corrected to "10.".

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20055563
• Report Number: 9614641-2024-01708
• Device Sequence Number: 8118193
• Product Code: FCG
• UDI-Device Identifier: 04953170380402
• UDI-Public: 04953170380402
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: NA-U200H-8019
• Device Lot Number: 2ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 01/31/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 01/31/2025; 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GF-UCT260.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown