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

Model Number NA-201SX-4021

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus 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

We received the following report.*during an endobronchial ultrasound-guided transbronchial needle aspiration (eus-tbna), the subject device was used.When the user inserted the needle into the tissue, it was found that the buckle was not fixed, which could not control the length of the needle.As a result, the needle nearly pierced the blood vessels.The intended procedure was completed with another device.There was no patient injury reported.

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.A photo of the defective part was provided.The convex part of the needle adjuster lever was deformed and crushed.The manufacturing record was reviewed and found no irregularities.The cause of the defect could not be identified because the actual product could not be confirmed and there was no abnormality in the manufacturing record.However, from similar events in the past, it is possible that the event the user pointed out 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.The above device handling has warned in the instruction manual.

• 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: 11009832
• MDR Text Key: 221557647
• Report Number: 8010047-2020-10362
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170240935
• UDI-Public: 04953170240935
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NA-201SX-4021
• Device Lot Number: 07K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1