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

Model Number NA-201SX-4022

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned and is pending evaluation.The cause of the reported event cannot be determined at this time.

Event Description

The service center was informed that during a diagnostic endobronchial ultrasound (ebus) procedure, the locking mechanism of the vizishot needle would not lock.The intended procedure was completed with a similar device.There was no patient injury.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results.The customer returned a quantity of one na-201sx-4022 single-use aspiration needle (lot 82v08) to mq for evaluation due to "locking mechanism of the na-201sx-4022 vizishot needle would not lock".The user's complaint was not confirmed during the evaluation.A visual inspection was performed on the received condition and was unable to replicate the user's experience during the evaluation.A large kink below the insertion portion boot close to the handle section was noted.The device was received with the stylet knob and wire intact; however, the stylet wire was unable to be maneuvered within.The needle at the end appears to be in good condition; no wear or other anomalies.The needle adjuster lever (locking lever), which keeps the slider handle from being manipulated, had no issues during testing.Further evaluation was performed and the connecting slider was tested with bf-uc180f video scope, along with the maj-1414 (single-use biopsy valve adapter), and the aspiration needle connected securely and kept itself locked in place during the duration of the testing.Without this biopsy valve adapter, it is likely that the aspiration needle would not lock in place.The ifu for the aspiration needle instructs using the maj-1414 adapter."-single use adapter biopsy valve (maj-1414) attached to the instrument channel port of the endoscope to connect the handle section to the endoscope." the content of this complaint was reviewed by the legal manufacturer (lm).The lm reported that since the actual product complaint could not be confirmed and there were no abnormalities in the manufacturing records, the cause of occurrence could not be conclusively identified.However, it is possible that the phenomenon based on similar examples occurred due to the following factors.It is presumed that the needle adjuster lever could not be locked because the convex part of the needle adjuster lever was deformed and it was difficult to fit in the groove near the scale on the handle.It is speculated that the convex part of the needle adjuster lever was deformed because it was slid to the convex part instead of the groove near the scale on the handle.

• 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: 10272394
• MDR Text Key: 223651379
• Report Number: 8010047-2020-04400
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170381928
• UDI-Public: 04953170381928
• 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: 09/22/2020

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-201SX-4022
• Device Lot Number: 82V 08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1