MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT WATER SUPPLY UNIT(FOR ULTRASONIC ENDOSCOPE)

Model Number	UWS-1
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the water supply unit was used to inject water, but a three-way stopcock was not properly closed, causing the patient¿s bodily fluids to flow back into the unit¿s tank.The patient had hepatitis c, and blood was found in the tank, indicating contamination.The issue occurred during a diagnostic gastroduodenal endoscopy and ultrasound examination.The procedure was completed using the same set of equipment.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over (18) years since the subject device was manufactured.Based on the results of the investigation, the cause of backflow was concluded that the surgeon did not close the three-way stopcock after injecting water.A labeling review was conducted using the product label uws-1 and confirmed that an instruction to move the three-way stopcock¿s lever to the ¿close¿ position to stop the water supply.Refer to ¿4.2 operation with the ultrasonic probe,¿ step 6, warning.6.Move the three-way stopcock¿s lever to the ¿close¿ position to stop the water supply.Warning: always close the three-way stopcock immediately after water is injected through this product.Failure to do so may cause backflow of intracorporeal contaminants, which may lead to infection.In the unlikely event that you forget to close the three-way stopcock, wash and disinfect (or sterilize) it immediately after the case is over.Olympus will continue to monitor field performance for this device.

• Brand Name: WATER SUPPLY UNIT(FOR ULTRASONIC ENDOSCOPE)
• Common Device Name: WATER SUPPLY UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19645266
• Report Number: 3003637092-2024-00116
• Device Sequence Number: 15335186
• Product Code: IYO
• UDI-Device Identifier: 04953170064142
• UDI-Public: 04953170064142
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: UWS-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2006
• 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
• Patient Sex: Unknown