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

Model Number	NA-201SX-4022
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned to olympus for evaluation.The investigation is ongoing, a supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, the single use aspiration needle adjuster could not be locked during the puncture process, thus the puncture site could not be fixed.The issue was found during a diagnostic pulmonary lymph node puncture biopsy, the procedure was completed with a similar device, and without delay.The patient was under general anesthesia, and there were no reports of patient harm or injury.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h4, h6 and h10.H4: based on the 3 digit lot number provided, the manufacturing date of the device was in the month of june 2022 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.The device was not returned to olympus as the customer reported discarding it, therefore the root cause of the needle adjuster not being able to be fixed was unable to be identified.However, it¿s likely the needle adjuster lever was not pushed straight, and a diagonal force was applied to the needle adjuster lever, which deformed the needle adjuster lever and prevented it from sliding in the locking direction.The following is included in the instructions for use: ¿before pushing the needle slider, confirm that the needle adjuster is fixed firmly.Be sure to firmly fix the needle adjuster.Otherwise, it could cause excess extension of the needle from the distal end of the sheath and perforation, bleeding, mucous membrane damage may result.If you feel excessive resistance while operating the needle adjuster lever, release the needle adjuster lever once and fix it again.Otherwise, it could damage the needle adjuster lever and patient injury, such as perforation, bleeding, or mucous membrane damage could result pull the needle slider on the hand side until you feel a click.¿ 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: 17204856
• Report Number: 9614641-2023-00910
• Device Sequence Number: 17584506
• Product Code: FCG
• UDI-Device Identifier: 04953170389900
• UDI-Public: 04953170389900
• 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): 07/24/2023

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: 26K
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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: BF-UC260FW EVIS LUCERA BRONCHOFIBERVIDEOSCOPE.
• Patient Sex: Unknown