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

Model Number NA-U401SX-4021

Device Problem Defective Device (2588)

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

Event Date 10/15/2021

Event Type  malfunction  

Event Description

As reported, the customer needle did not work when they were setting it up.The locking was too tight and when they finally released it would not tighten back up.There is no patient involvement associated on this reported event.No user injury reported.

Manufacturer Narrative

The subject device has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported phenomenon could not be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This supplemental report is to inform that upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 12783646
• MDR Text Key: 282189212
• Report Number: 8010047-2021-14357
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• 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: PW307515
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: No
• 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