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

Model Number NA-U401SX-4021

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2022

Event Type  malfunction  

Event Description

It was reported that the device na-u401sx-4021 needle does not stay locked.The intended case as reported by the reporter, was completed with a second like device.There was no patient harm or injury reported due to the event.No user injury reported.

Manufacturer Narrative

The device single use aspiration needle na-u401sx-4021, physical lot# kr199779, packaging lot# kr199772, expiry date 2024-12-15 was returned for evaluation.Device evaluation, the following were noted: visual inspection as received condition found the red protective plate and gray stopper had already been removed by user.There are deep screw marks on the shaft and the sheath adjuster knob was in locked position.The needle adjuster could slide up and down the scale smoothly and its lever was able to lock in place as intended.The needle slider could extend the needle tip all the way about 35mm from the distal green sheath or retract the needle when pulled until it clicked at the double arrow marks.Observed that the needle was bent at the distal section, and there is biomaterial adhered on the needle tip indicating used.The device was then checked with olympus test endoscope bf-uc180f, noted that the connecting slider could attach to the scope and fit properly on the test biopsy valve maj-1414.The handle section is functioning correctly as it could extend or retract the needle without a problem.The stylet is also present and working, and no indication of physical damage on the coil sheath working length.Based on the evaluation findings, the reported complaint of needle not stay locked was not duplicated.There is no issue with any locking parts of the device.Legal manufacturer investigation and conclusion: the dhrs (device history records) for this product have been reviewed.No abnormalities were detected in the device history record with the lot number for the following inspection items which related to the reported phenomenon.Process inspection sheet.Quality inspection sheet.Nonconforming product report.Ifu (instruction for use): content of the instruction manual (drawing number: gk9898 /revision number: 4) was confirmed.The instruction manual contains the following descriptions related to this phenomenon.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.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.Conclusion summary: based on the results of the investigation, a definitive root cause could not be established.An evaluation of the device could not confirm the suggested phenomenon.Device evaluation, the reported phenomenon was not reproduced.There was no abnormality in the manufacturing record.From the results of past investigations, it is probable that the reason why the needle adjuster could not be locked was not because of the groove near the scale on the handle, but because the needle adjuster lever was slid to a convex position.It was not possible to identify the cause.No complaint trend abnormalities were detected in the (feb./2022) quality data analysis for the following events.Phenomenon: needle adjuster lever not locked.Olympus will continue to monitor complaints for this device.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.¿.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• Type of Device: 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: 14505490
• MDR Text Key: 300381489
• Report Number: 8010047-2022-08923
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170388248
• UDI-Public: 04953170388248
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U401SX-4021
• Device Lot Number: KR199772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1