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

Model Number NA-201SX-4021

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As the device was not returned for evaluation, we are unable to determine a root cause for the reported event.If additional information becomes available or the device is returned for evaluation, a supplemental report will be filed.

Event Description

The user facility reported that the na-201sx-4021 vizishot needle shipment was damaged upon arrival.A request was made to return 2 boxes of damaged needles.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-06109.The original equipment manufacturer (oem), performed a device history record review and no abnormalities were noted.No device was returned to the oem, however, an investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.Since this product has been thoroughly inspected by ovnc and logitec for the appearance of the individual packaging box, it is judged that the individual packaging box was not damaged at the time of shipment and there was no problem.It is presumed that some kind of load was applied to the individual packaging box after shipment and the reported event, but the occurrence status could not be identified.Olympus will continue to monitor the field performance of this device.

• 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: 10482853
• MDR Text Key: 205306342
• Report Number: 8010047-2020-06109
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K050503
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-201SX-4021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1