MAUDE Adverse Event Report: STERIS CORPORATION HEXAVUE INTEGRATION SYSTEM

Model Number	HexaVue-SLC 1.0
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their hexavue integration system had no power.There was a procedure delay as user facility personnel connected the surgical equipment directly to stand alone monitors to complete the procedure successfully.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the hexavue integration system and found that the isolation transformer (iso puck) had been damaged which caused the universal power supply (ups) and the central processing unit (cxp cpu) of the system to stop working properly.The purpose of the iso puck is to deliver clean and constant power from the wall outlet to the hexavue integration system, and to prevent current leakages or spikes.The technician plugged the system directly into the wall outlet, and power was restored to the system.The user facility continued to use the system plugged into the wall outlet until the necessary repairs were made.The technician replaced the iso puck and cpu, tested the system, and returned it to service.No additional issues have been reported.

• Brand Name: HEXAVUE INTEGRATION SYSTEM
• Common Device Name: INTEGRATION SYSTEM
• Manufacturer (Section D): STERIS CORPORATION; 503 canal blvd.; richmond CA 94804
• Manufacturer (Section G): STERIS CORPORATION; 503 canal blvd.; richmond CA 94804
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16815242
• Report Number: 3008776287-2023-00004
• Device Sequence Number: 5682736
• Product Code: KQM
• UDI-Device Identifier: 00724995198497
• UDI-Public: 00724995198497
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2023

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: HexaVue-SLC 1.0
• Device Catalogue Number: XQHLC1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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