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

Model Number	CV-150
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the video system center had no image coming while using the red, green and blue (rgb) cable during preparation for use for a diagnostic bronchoscopy.The intended procedure was cancelled so there was no health impact on the patient.Upon inspection and evaluation, no image on monitor screen due to burnt distribution panel (dp) board.There was no report of patient harm or user injury associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunctions found during incoming inspection and evaluation.
Additional Manufacturer Narrative
Establishment name: sai tirupati university, pacific institute of medical sciences the device was returned to olympus for inspection, and the customer's reported issue ¿no image coming while using the red, green and blue (rgb) cable¿ was confirmed.The following findings were also noted during device evaluation: equipment not getting on due to faulty power supply, scope socket found broken, limit switch and lamp socket found damage, one screw in chassis found broken, front panel found broken, heavy dent on top cover, heavy dent on rear panel, and dent found on pump base.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.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of 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 seven (7) years since the subject device was manufactured.Based on the investigation results, the root cause could not be identified, however, it is likely that the malfunction was caused by the burned printed circuit board.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEO SYSTEM CENTER
• 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: 17762865
• Report Number: 3002808148-2023-09935
• Device Sequence Number: 6664320
• Product Code: FDF
• UDI-Device Identifier: 04953170238857
• UDI-Public: 04953170238857
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: CV-150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2016
• 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