MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE); FORCEPS/ IRRIGATION PLUG

Model Number	MAJ-891
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that three patients presented with sepsis after procedures using a cysto-nephro videoscope with forceps/irrigation plug devices.No additional relevant clinical information was provided by the reporter.Olympus made multiple attempts to receive more information from the customer without success.This report is related to the following linked patient identifiers: (b)(6).

• Brand Name: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Common Device Name: FORCEPS/ IRRIGATION PLUG
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 22463033
• Report Number: 2429304-2025-00204
• Device Sequence Number: 12901629
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2025
• Report Date (Section F): 07/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/10/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CYF-V2 VISERA CYSTO-NEPHRO VIDEOSCOPE
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/09/2025