MAUDE Adverse Event Report: STERIS CORPORATION STERIS; SURGICAL TABLE

Model Number	5095 SURIGICAL TABLE
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the table and found the floor locks would not respond to the hand control.The technician adjusted the floor lock manifold assembly to resolve the reported issue.The table was tested, confirmed to be operating according to specifications, and returned to service.No additional issues have been reported.
Event or Problem Description
The user facility reported the floor locks to their 5095 surgical table would not engage properly.User facility personnel had to manually lock the table, resulting in a short delay in a patient procedure.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The device history record for the 5095 surgical table was reviewed and no abnormalities were found.

• Brand Name: STERIS
• Common Device Name: 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: 21336784
• Report Number: 1043572-2025-00013
• Device Sequence Number: 8441665
• Product Code: FQO
• UDI-Device Identifier: 00724995195649
• UDI-Public: (01)00724995195649(11)240924
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 5095 SURIGICAL 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: 01/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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