MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET

Model Number	NM-400U-0423
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the single use injector had a rusty needle.This was found during preparation for use; there was no patient involved.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated field(s): d4, d8, h2, h3, h6, h11.The device was returned to olympus for inspection; however, the reported failure was not confirmed.Based on the results of the investigation, and since the device malfunction was not confirmed during evaluation, a definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
No additional information received from customer.

• Brand Name: SINGLE USE INJECTOR
• Common Device Name: INJECTOR AND SHEATHSET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23705533
• Report Number: 9614641-2025-01988
• Device Sequence Number: 10691664
• Product Code: FBK
• UDI-Device Identifier: 04953170259876
• UDI-Public: 04953170259876
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K902736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: Health Professional
• Device Model Number: NM-400U-0423
• Device Lot Number: K3Z01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown