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

Model Number NA-201SX-4022

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During an unspecified procedure, the subject device was used.The needle adjuster lever could not be locked.The intended procedure was completed with another device.There was no patient injury reported.This is the report regarding the inability to fix the needle adjuster lever.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.When the needle adjuster level was slid, the needle tube could be fixed and released although there was resistance.The convex part of the needle adjuster lever was deformed.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it is presumed that the needle tube could not be locked since the needle adjuster lever was slid not to the groove near the scale on the handle but to the convex part, and then the convex part of the needle adjuster was deformed and not fixed to the right position.

• 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: 10166338
• MDR Text Key: 223827873
• Report Number: 8010047-2020-03451
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170389887
• UDI-Public: 04953170389887
• Combination Product (y/n): N
• PMA/PMN Number: K050503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NA-201SX-4022
• Device Lot Number: 9XV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• 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