MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. MEDICAL CONTROL UNIT FOR ENDOSURGERY; SYSTEM INTEGRATION

Model Number	UCES-4
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that, during an unspecified procedure, the intended program could not be controlled with the subject device.The user restarted the system which resulted in the monitors remaining dark and an interface error message appearing on the screen of the non-olympus high frequency device.The cabling was checked and the system was restarted again.The wall monitor remained dark and a disc error message appeared on the monitor of the extra arm.After another restart, the extra monitor remained dark and the image on the wall monitor appeared as expected.The procedure was completed by setting the examination manually on the non-olympus device.There was no effect on the patient due to the event.
Additional Manufacturer Narrative
The suspect device has not been received at olympus for evaluation.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on 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.Based on the results of the investigation and because the subject device was not returned, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported that the event occurred prior to an unspecified procedure.

• Brand Name: MEDICAL CONTROL UNIT FOR ENDOSURGERY
• Common Device Name: SYSTEM INTEGRATION
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15503202
• Report Number: 3002808148-2022-02554
• Device Sequence Number: 5212602
• Product Code: GCJ
• UDI-Device Identifier: 04953170391767
• UDI-Public: 04953170391767
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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: UCES-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2016
• 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