MAUDE Adverse Event Report: Olympus Vietnam Co. Ltd. Single Use Injector; INJECTOR AND SHEATHSET

Model Number	NM-401L-0623
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction

• Brand Name: Single Use Injector
• Common Device Name: INJECTOR AND SHEATHSET
• Manufacturer (Section D): Olympus Vietnam Co. Ltd.; 8 street, long thanh ind. zone; an phuoc commune; dong nai province 81000 0; VM 810000
• Manufacturer (Section G): Olympus Vietnam Co. Ltd.; 8 street, long thanh ind. zone; an phuoc commune; dong nai province 81000 0; VM 810000
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50673679
• Report Number: 3008040402-2026-00301
• Device Sequence Number: 9272358
• Product Code: FBK
• UDI-Device Identifier: 04953170453632
• UDI-Public: 04953170453632
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K252247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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-401L-0623
• Device Lot Number: 41V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown