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

Model Number NA-U401SX-4021

Device Problems Defective Device (2588); Output Problem (3005)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported phenomenon could not be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigations.

Event Description

It was reported that during an unknown event, the user was using the na-u401sx-4021 vizishot needle and was unable to use the locking device properly, it would not lock.The user put it to the side and used another vizishot needle with no incident.There was no patient harm or injury reported due to the event, no user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates.The following sections were updated: e2, e3,g3, g6, h2, h6 and h10.Further communication with the customer conveyed the following information: there was an ebus in progress when the issue occured.The intended procedure was completed, a second needle was used successfully.Procedure was an ebus.No other information provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Based on the results of the investigation and information gathered, the root cause cannot be conclusively identified as the device was not retuned for investigation.Review of dhr (device history record) found no abnormalities in the manufacturing record.Therefore, the phenomenon which was pointed out could not be confirmed.From the results of past investigations, 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.However, the exact cause of the needle break could not be identified.As stated on the ifu (instruction for use) the user manual states: ·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 complaints for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on device evaluation.Customer returned a single use aspiration needle model number na-u401sx-4021 lot number kr130378 for evaluation due to ¿unable to use the locking device properly, it would not lock¿.The lot# kr136388 on the initial mdr report was for the package batch lot but the actual lot number of the device is lot no.Kr130378 and is noted in d4 for this report.The device was returned without the original packaging.Visual inspection performed on the ¿as received¿ condition and observed no damage to the locking mechanism, handle, or slider.The device was returned with the stylet still intact.The needle tip appeared to be sharp, however visual residue is on the distal end, indicating the device has been used.In addition, inspection performed on the insertion portion by running two fingers down the entire length of the insertion tube and found 2 bends.A functional check was performed by pushing the needle adjuster to right to lock in place.It was noted the needle adjuster was able to lock in various section on the scale without an issue.The sheath adjuster knob was also tested and found it working as normal.The sheath adjust knob was to be come loosen and tighten to lock in place.Based on device evaluation, although bends on insertion tube was found, the customer reported issue was not confirmed as no issue found on locking mechanism of the device.Olympus will continue to monitor complaints for this device.Supplemental report(s) will be submitted should any relevant new information is available and or received.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to d8, g2, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the needle could not be fixed because the needle adjuster was fixed in the convex position instead of the groove near the scale on the handle.In addition, it is likely the bending of the needle tube was caused by inserting it into the endoscope, setting the angle of the endoscope tightly, and inserting and removing the needle tube.However, the exact cause of the needle break could not be identified.The following is included in the instructions for use: ¿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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12276887
• MDR Text Key: 265615773
• Report Number: 8010047-2021-09798
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170388248
• UDI-Public: 04953170388248
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U401SX-4021
• Device Lot Number: KR130378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 08/06/2021; 09/14/2021; 09/20/2022; 11/22/2022
• Supplement Dates FDA Received: 08/13/2021; 09/14/2021; 10/13/2022; 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2021
• 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