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

Model Number NA-201SX-4021

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user report was unable to be confirmed.The device was received with biomatter present on the needle from use.The tip of the needle was slightly bent, but nothing was missing.The adjuster and its lever were intact and functioning properly.It was sliding up and down the scale smoothly, not loose, and was properly locking and releasing without restriction.Furthermore, the slider could also extend the needle from the sheath or retract the needle when pulled until it clicked at the marks, and the adjuster lever could lock the slider in place properly.If additional information becomes available following device evaluation, a supplemental report will be filed.

Event Description

It was reported, the needle locking mechanism on the single-use aspiration needle was loose.According to the initial reporter, it did not appear to be locking in place.This event did occur during a procedure; however, no patient harm or consequence was reported as a result of this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), a review of the instructions for use (ifu), as well as a historical trending analysis were conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿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.¿.From the results of the investigation, it is probable that the reason why the needle could not be fixed was not because of the groove near the scale on the handle, but because the needle adjuster was fixed in a convex position.Regarding the bending of the needle, it is probable that the needle had a bending habit because it was used in the procedure.Olympus will continue to monitor the field performance of this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• 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: 11992233
• MDR Text Key: 264180792
• Report Number: 8010047-2021-07492
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170381911
• UDI-Public: 04953170381911
• Combination Product (y/n): N
• PMA/PMN Number: K050503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-201SX-4021
• Device Lot Number: 09V 03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1