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 Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported in complaint (b)(4), the back and forth mechanism malfunctioned during a procedure.The customer also reported this was the second time this issue happened with the same batch.No additional information is available.This is for event 2 of 2 with patient (b)(6).

Manufacturer Narrative

The suspect device will not be returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The actual device was not returned however, a device from the same serial/lot was returned under patient identifier c21338897.A visual inspection was performed and the appearance was within normal limits, no damages.The needle tip was bent with visible residue indicating the device had been used.A functional check was performed on the device and the distal end corresponded with the slider however force had to be applied when extending the distal end out of the sheath.Both the sheath adjuster knob and needle adjuster held their position when engaged.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to the needle adjuster lever was slid to a convex position and the needle tip was bent due to puncturing a hard object or excessive force.The instructions for use includes information to prevent this issue: "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." olympus will continue to monitor field performance for this device.

• 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: 12413830
• MDR Text Key: 280950603
• Report Number: 3011050570-2021-00100
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170388323
• UDI-Public: 04953170388323
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• 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: KR120527
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1