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

Model Number NA-201SX-4022

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.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.In the procedure, the needle adjuster could not be locked.There was no patient injury reported.The subject device was discarded by the user.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.Four unopened suction biopsy needles were returned.As a result of checking the operation of the needle adjuster of unopened devices, there was no problem.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc presumes 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: 10940030
• MDR Text Key: 219355799
• Report Number: 8010047-2020-09765
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1