MAUDE Adverse Event Report: STERIS CORPORATION STERIS; 5095 SURGICAL TABLE

Model Number	5095 SURGICAL TABLE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the floor locks to their 5095 surgical table were not operating properly.The patient was transferred to a different surgical table and the procedure was completed successfully following a short delay.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the 5095 surgical table.The technician tested the function and operation of the 5095 surgical table and found the device to be operating to specifications.No issues were noted with the floor locks and the reported event was unable to be duplicated.The 5095 surgical table was returned to service, and no additional issues have been reported.

• Brand Name: STERIS
• Common Device Name: 5095 SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 21778670
• Report Number: 1043572-2025-00034
• Device Sequence Number: 15660752
• Product Code: FQO
• UDI-Device Identifier: 00724995195649
• UDI-Public: (01)00724995195649(11)240530
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5095 SURGICAL TABLE
• Device Catalogue Number: ST015211002
• 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: 03/06/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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