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

Model Number NA-U200H-8022

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc).The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During inspection before use, the foreign object was found in the sterile package.The intended procedure was completed with another device.There was no patient injury reported.This is the report regarding the foreign object in the sealed sterile package.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The sterile package was opened.A black foreign object which was not a component of the subject device was also returned.A foreign material adhered to the tip of the insertion part.The manufacturing record was reviewed and found no irregularities.The root cause could not be identified because the sterile package was opened and there were no problems with the manufacturing records.

• 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
• MDR Report Key: 10294082
• MDR Text Key: 199565108
• Report Number: 8010047-2020-04584
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K151738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• 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: 9ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1