MAUDE Adverse Event Report: STERIS CORPORATION HEXAVUE INTEGRATION SYSTEM

Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the hexavue integration system and found that hard drive required replacement.The technician replaced the hard drive, tested the hexavue integration system and confirmed it to be operating properly.The hexavue integration system was returned to service and no additional issues have been reported.A complaint review determines this to be an isolated event.
Event or Problem Description
The user facility reported that during a patient procedure their hexavue integration system lost signal and would not display the image.User facility personnel connected the hexavue integration system directly into the wall monitor to complete the procedure.The procedure was completed successfully, and no injuries were 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: 17508974
• Report Number: 3008776287-2023-00009
• Device Sequence Number: 15028421
• Product Code: KQM
• UDI-Device Identifier: 00724995198497
• UDI-Public: 00724995198497
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/11/2023

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
• 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: 07/13/2023
• Initial Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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