MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number NA-U200H-8022

Device Problem Mechanical Problem (1384)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus for evaluation.It was noted that the guidewire was inserted and protruding from the tip of the sheath and the needle tube was not protruding when the components were received.Upon inspection and testing of the device, the reported complaint was confirmed.The guidewire could not be moved in the needle in either direction.The needle tube was bent at about 450mm from the tip of the insertion unit and what appeared to be contrast media was adhered to the entire insertion unit.When the needle slider was pushed in, there was resistance and the needle tube did not come out of the sheath.The needle slider was disassembled and the needle tube was found to be deformed.An attempt to pull out the needle tube to check the needle tip was made, but it would only move approximately 100mm.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The physician reported that while preparing for a therapeutic endoscopic ultrasound-guided biliary drainage procedure, although the guidewire passed through the needle, it was difficult to insert the guidewire into the needle, so the lumen of the needle may have been narrow.The customer reported that during the procedure, after puncturing the tissue with the biopsy needle, the guidewire was caught in the biopsy needle upon insertion and it became impossible to pull out the guidewire.The entire endoscope was removed by pulling the needle and guidewire out together, prior to removing the endoscope.The procedure was stopped and subsequently cancelled.The physician noted that even after removing the needle and guidewire from the endoscope, the guidewire could not be removed from the needle.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed the reported device problem.A review of the device history record found no deviations that could have caused or contributed to the reported device problem.A definitive root cause for the reported product problem was not established.However, it was probable that the reported issue occurred because the end-user had inserted a guidewire with an outer diameter that was larger than the inner diameter of the narrow section of the needle tube.Additionally, it is also probable that the deformation of the needle tube increased the sliding resistance between the guide wire and the needle tube; making it impossible to insert and remove the guide wire.The insertion section of the needle tube may have also buckled under the following circumstances: when removing from the tray, a bending load was applied to the needle tube.During the pre-use inspection, a bending load was applied to the needle tube.When inserting and removing the endoscope, a bending load was applied to the needle tube.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• 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: 13523551
• MDR Text Key: 296318686
• Report Number: 8010047-2022-02899
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170380488
• UDI-Public: 04953170380488
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U200H-8022
• Device Lot Number: 19K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• 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
• Treatment: E0018450AG-2: OLYMPUS FIELDER GUIDEWIRE SET; GF-UCT260 OLYMPUS EVIS LUCERA U/S GASTROVIDEOSCOPE