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

Model Number	MAJ-901
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No serial number was provided.The subject device has not been returned to olympus for evaluation.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus, when liquid was put through the water container, dust came out of the tube of the device, indicating possible insufficient reprocessing.Patient identifier (b)(6) captures a complaint on evis lucera elite gastrointestinal videoscope (model number: gif-xp290n, serial number: (b)(6) ) with a similar insufficient reprocessing issue.There was no harm or user injury reported due to the event.
Event or Problem Description
The event occurred before an unspecified procedure.There was no patient harm reported.It is unknown if there is a delay in procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Section b5 was updated with additional information about the event.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reprocessing issue could not be determined.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: 16809405
• Report Number: 3002808148-2023-04158
• Device Sequence Number: 6182182
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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-901
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 07/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MODEL NUMBER: GIF-XP290N, SERIAL NUMBER: (B)(6) .
• Patient Sex: Unknown