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

Model Number NA-U401SX-4022

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the customer's experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported a single use aspiration needle would not lock.The sheath would not stay locked and the needle came out puncturing the insertion tube of the scope.There was no patient impact related to this occurrence.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned and evaluated, however the reported issue was not confirmed.Based on the results of the legal manufacturer's investigation, from the results of past investigations, it is likely that the reason why the needle could not be fixed is due to the needle adjuster being in a convex position.A review of the instruction manual confirms the following verbiage: "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, and/or mucosal damage".

• 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
• MDR Report Key: 11237410
• MDR Text Key: 229606196
• Report Number: 8010047-2021-01928
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170388286
• UDI-Public: 04953170388286
• Combination Product (y/n): N
• PMA/PMN Number: K160098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U401SX-4022
• Device Lot Number: KR108363
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1