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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cysto-nephro videoscope was incorrectly reprocessed.The forceps/irrigation plug separated into only three parts; after clarification that it disassembles into four, customer immediately pulled all forceps/irrigation plug devices and reprocessed them according to the instructions for use.The issue occurred during maintenance.There were no reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation and correction.Updated fields: d4 (lot #, model #), h2, h6 and h11.Corrected fields: b5, d1, d2a, d2b, d3, d4, d10, g1, g4 and h6.Correction to d10: the d10 field should be blank as there are no concomitant devices involved in the event.The device was not returned to olympus for inspection.However, the ess reviewed reprocessing guidelines from the user and reprocessing manuals, with emphasis on proper disassembly.After clarification that the forceps plug disassembles into four parts, the customer pulled all irrigation plugs and reprocessed them according to the instructions for use (ifu).The ess provided training and copies of the instructions for use.Based on the results of the investigation, the most probable cause of the complaint is failure to follow instructions.The event can be prevented by following the ifu which states: "be sure to disassemble the forceps/irrigation plug before it is cleaned, disinfected or sterilized.Otherwise, the forceps/irrigation plug may not be properly cleaned/disinfected/sterilized." should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Correction to b5 for information inadvertently left out of previous report: it was reported by the endoscopic support specialist (ess) that the customer disassembled the forceps irrigation plug into three parts instead of four parts during reprocessing.The issue was identified during a reprocessing in-service.There were no reports of patient harm associated with the event.

• Brand Name: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Common Device Name: FORCEPS/ IRRIGATION PLUG
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; odakura, nishigo-mura,; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; odakura, nishigo-mura,; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22494797
• Report Number: 3002808148-2025-10596
• Device Sequence Number: 4145908
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K912120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: MAJ-891
• Device Lot Number: 2921744
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED AUTOMATIC ENDOSCOPE REPROCESSOR (AER); UNSPECIFIED MAJ-891 FORCEPS/IRRIGATION PLUG
• Patient Sex: Unknown