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

Model Number	UCES-4
Medical Device Problem Codes	No Display/Image (1183); Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the medical control unit for endosurgery could not control the light source for endosurgery, the image was not visible and there was no power.The issue occurred during an unspecified procedure.There were no reports of patient harm associated with the event.
Additional Manufacturer Narrative
This supplemental report is to provide a correction to the initial medwatch report (mdr) as there were no reportable malfunction related to the subject device captured in this complaint.The initial medwatch incorrectly reported that the subject device could not control the light source for endosurgery and the image was not visible.The customer only alleged that the subject device did not have power.The customer confirmed the event occurred prior to a procedure and there was no delay or impact to the patient.Per the legal manufacturer, this issue of no power is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• 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 (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: 19680506
• Report Number: 3002808148-2024-06099
• Device Sequence Number: 6835968
• Product Code: GCJ
• UDI-Device Identifier: 04953170391767
• UDI-Public: 04953170391767
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: UCES-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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