MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VIDEO SYSTEM; VIDEO SYSTEM CENTER

Model Number	OTV-SI
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the video system's illumination light adjustment function is not properly controlled, and the illumination light is too bright.The issue was found during a diagnostic cystoscopy and a stent removal.The provider had a difficult time navigating and viewing the inside of the patient's bladder due to extreme brightness.Removal of a kidney stent was especially difficult.The procedure was delayed but was completed with the same device.There were no reports of patient harm or injury.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.Correction: d8 corrected to yes as the customer used a non-olympus lamp.The olympus service center found the users event of the light being too bright confirmed due to the users setting.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, it was confirmed the users setting were set incorrectly which occurred due to the user.However, the specific root cause of the user setting the light too bright could not be determined at this time.The following information is stated in the instructions for use (ifu): "warning always set the minimum required brightness.The brightness of the image on a video monitor may differ from the actual brightness at the distal end of the endoscope.The automatic brightness control function can maintain proper illumination.Do not prolong observation in close proximity to tissue or keep the distal end of the endoscope in contact with living tissue." olympus will continue to monitor field performance for this device.

• Brand Name: VIDEO SYSTEM
• Common Device Name: VIDEO SYSTEM CENTER
• 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: 18097750
• Report Number: 3002808148-2023-12506
• Device Sequence Number: 8051483
• Product Code: FET
• UDI-Device Identifier: 04953170169885
• UDI-Public: 04953170169885
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: OTV-SI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2010
• 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