MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX

Model Number	NA-U401SX-4022
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for evaluation.The user discarded the device.Investigation is ongoing.This report will be supplemented accordingly following investigation completion.
Event or Problem Description
As reported, customer reported of "difficulty in fixation of the needle" (it moves easily even with the maximum fixation).Very difficult to penetrate the tracheal wall, lymph node structure and in the back and forth movements.Deformation of the needle with the use.Very poor ultrasound visualization.The event occurred during a procedure (ultrasound guided puncture).No patient damaged.No extension of the procedure as a result of the event.There was no patient harm or injury reported due to the event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the following mechanisms likely caused the event: -the needle adjuster was likely not locked.-the needle adjuster lever might have slid to a convex area instead of a groove near the scale of the handle causing the needle adjuster not to lock.-the insertion portion of the endoscope was excessively angulated while the needle was extended and retracted causing the needle to bend.-the ultrasonic of the scope could not recognize the needle tube causing it to not be visible on the ultrasound image.The specific root cause could not be determined at this time.The following information is stated in the instructions for use (ifu): "-before pushing in the needle slider, make sure that the needle adjuster is firmly fixed.If the needle adjuster is not firmly fixed, the needle may pop out from the tip of the sheath beyond the intended length, leading to perforation, major bleeding, and mucosal damage.-when fixing the needle adjuster lever, if there is resistance during the operation of fixing the needle adjuster lever, release the needle adjuster lever once and fix it again.Forcibly fixing the needle while there is resistance may damage the needle adjuster lever, prevent the needle adjuster from being fixed, and cause the needle to protrude beyond the intended length, leading to perforation, major bleeding, mucosal damage, etc." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• 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: 13611190
• Report Number: 8010047-2022-03630
• Device Sequence Number: 1969139
• Product Code: FCG
• UDI-Device Identifier: 04953170388286
• UDI-Public: 04953170388286
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K160098
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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-U401SX-4022
• Device Lot Number: KR150706
• 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: 01/31/2022
• Supplement Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 02/26/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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: SCOPE BF-UC180F
• Patient Sex: Unknown