MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. WATER CONTAINER

Model Number	MAJ-901
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1/establishment name: (b)(6) added here due to character limitation in respective field.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
It was reported during an emergency diagnostic endoscopy examination at night, a patient was mistakenly given a detergent solution or alcohol to the water in the water container.It was estimated the detergent or alcohol went into the digestive tract.The facility staff realized that it had been used incorrectly after the procedure was completed.The doctors believe there would be little harm to the patient because it was not a large dose.The patient was under observation for a few days and then discharged.
Event or Problem Description
It was reported that the patient was originally hospitalized and observed for other reasons prior to the reported event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's (lm) investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The subject device was not returned to olympus for evaluation.Based on the results of the investigation, the root cause of the reported event could not be determined.This supplemental report includes additional information received from the customer.B5 updated accordingly.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's updated investigation.Based on the results of the updated investigation, it was judged that [liquid detergent or alcohol in the water tank has been accidentally poured into the patient] occurred due to misuse by the facility.The event can be detected/prevented by following the instructions for use which state: chapter 3 preparation and inspection 3.1 precautions for preparation and inspection warning: "do not use liquid other than sterilized water.It causes bacteria to grow in the water supply tube and clogging in the tubes." chapter 5 reprocessing 5.14 manually disinfecting the water container warning "residual disinfectant may adversely affect patients.After disinfection, thoroughly rinse the water supply tank with water to remove any residual disinfectant." olympus will continue to monitor field performance for this device.

• Brand Name: WATER CONTAINER
• Common Device Name: WATER CONTAINER
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18916553
• Report Number: 3002808148-2024-02488
• Device Sequence Number: 20593709
• Product Code: FDF
• UDI-Device Identifier: 04953170022913
• UDI-Public: 04953170022913
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: MAJ-901
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 05/01/2025; 06/23/2025
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 05/08/2025; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian