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

Model Number	NA-201SX-4022
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, during the operation in the airway cavity, the single use aspiration needle could not be visualized after multiple punctures, and there was resistance to retracting the needle back into the tube sheath; the operation was later interrupted and the syringe was withdrawn and examined, and it was found that the needle was exposed outside of the tube sheath and had been bent.The issue occurred during a therapeutic transbronchial needle aspiration (tbna) procedure.The intended procedure was completed using a similar device and there were no reports of patient injury or harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field h4: based on the 3-digit lot number provided, the manufacturing date of the device was in the month of apr 2023, but a specific date could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 years since the subject device was manufactured.The device was not returned to olympus for inspection, and the customer's malfunction was not confirmed.Based on the results of the investigation, it was reported that the issue may have occurred because the needle tip got caught on the side of the sheath or penetrated the sheath, making it impossible to eject the needle, however, the exact root cause could not be determined.The event can be detected/prevented by following the instructions for use which state: ·when inserting the instrument into the endoscope, the distal end of the needle tube may be bent.When piercing the target, confirm the distal end of the sheath and needle tube in the endoscopic field of view and/or ultrasound image while considering such bending.Otherwise, patient injury such as perforation, bleeding, or mucous membrane damage may occur.Do not try to straighten a bent or deformed needle with your hands because the needle may break.Use a spare needle instead.·do not coil the insertion portion with a diameter of less than 150 mm.Doing so could damage the instrument.¿ do not insert this instrument when the endoscope is angulated.This could damage the endoscope and/or this instrument.¿ do not insert the instrument abruptly.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or the instrument.·do not extend the sheath from the distal end of the endoscope without confirming it in the endoscopic field of view.Otherwise, it could cause patient injury, such as perforation, pneumothorax, bleeding, or membrane damage.It could also damage the endoscope and/or instrument.·do not push the endoscope's distal end against mucous membranes or insert it into narrow areas while the sheath is extended from the endoscope's distal end.When extended, the distal end of the sheath could cause patient injury, such as perforation, bleeding, or mucous membrane damage.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• 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: 19047780
• Report Number: 9614641-2024-00848
• Device Sequence Number: 15264436
• Product Code: FCG
• UDI-Device Identifier: 04953170180958
• UDI-Public: 04953170180958
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: NA-201SX-4022
• Device Lot Number: 34K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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
• Patient Sex: Unknown