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

Model Number	NA-201SX-4021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 8010047-2020-10362
• Device Sequence Number: 11902848
• Product Code: FCG
• UDI-Device Identifier: 04953170240935
• UDI-Public: 04953170240935
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1