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

Model Number NA-U401SX-4022

Device Problem Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

The na-u401sx-4022 needle was not returned to the service center for evaluation.The cause of the reported event cannot be determined at this time.However, the instruction manual does provide following warning statements below.When using the instrument, always wear appropriate personal protective equipment.Otherwise, blood, mucous, and other potentially infectious material from the patient could pose an infection control risk.Before use, prepare and inspect the instrument as instructed below.Should any irregularity be observed, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, such as posing an infection control risk causing tissue irritation, perforation, bleeding, or mucous membrane damage, and may result in more severe equipment damage.¿ in addition, an investigation is ongoing to obtain additional information regarding the reported event.If additional information is received or if the needle is returned at a later date, this report will be supplemented accordingly.

Event Description

The service cent was informed that during a procedure, while expelling the specimen from the tip of the needle the customer experienced difficulty and the pathologist was sprayed twice.The customer further investigated the needle and noticed the spray was coming from the green covering that meets the coil sheath at the connector.The reported that when expelling the specimen the needle was not extend out of the sheath, which may have caused the problem due to the fact the specimen was very large and clogged the tip.The customer believes this may have been the reason for specimen backing up in the sheath.It is unknown if the intended procedure was completed.There was no patient/user injury or infection reported.

Event Description

This issue occurred during a therapeutic procedure.There were no other devices involved in the event.There was no delay in the procedure in which the subject device was used.The procedure was completed with a different device, but the device used to complete the procedure is unknown.The device failed while expelling the specimen.The patient's pre-existing conditions and demographics were unable to be provided.It is noted that other devices were replaced during the procedure; however, further information regarding this was not provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on clarification provided by the customer and to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause is likely the liquid was pushed while the needle tube was housed in the coil sheath and the tip of the coil sheath was closed.This issue is addressed in the instructions for use (ifu): "slide the needle adjuster lever so that the needle adjuster can be slid, and then slowly push in the needle slider to protrude the tip of the needle tube from the sheath.".

• 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: 11118010
• MDR Text Key: 225186507
• Report Number: 8010047-2021-00878
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• 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: KR108364
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1