MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE

Model Number	NA-201SX-4021
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for evaluation.Based on legal manufacturer investigation, it was unable to confirm the event pointed out due to the actual product was not sent for evaluation.Review of the following dhrs (device history records) for the manufacturing lot number of the equipment, showed no abnormalities in the items related to the reported event.Process inspection slip.Quality inspection slip.Non-conforming product parts processing table.From the confirmation result of dhr, it is considered that there is no problem with the product.Therefore, it was judged that it is not necessary to investigate using equipment with the same structure or similar equipment.Review of ifu (instruction for use) the user manual states the following description.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.Conclusion summary: in the manufacturing process of this product, the operation of all needle adjusters were confirmed, therefore it is believe that there was no problem with the operation of the needle adjusters at the time of shipment.It is probable that the reason why the needle could not be fixed was not because of the groove near the scale of the handle, it was due to the needle adjuster was fixed in the convex position, however, the cause could not be identified.Olympus will continue to monitor complaints for this device.
Event or Problem Description
Olympus received maude mdr report key (b)(4) with a device issue stated "the needle lock function failed, preventing staff from securing needle while entering and exiting the airway".There are no further details provided in the report regarding the event/problem reported.There was no patient harm or injury reported on this reported event.No user injury reported.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12902234
• Report Number: 8010047-2021-15281
• Device Sequence Number: 4956054
• Product Code: FCG
• UDI-Device Identifier: 04953170381911
• UDI-Public: 04953170381911
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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: Other
• Device Model Number: NA-201SX-4021
• Device Lot Number: OYV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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