MAUDE Adverse Event Report: STERIS CORPORATION STERIS; SURGICAL TABLE

Model Number	4095 SURIGICAL TABLE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their steris 4095 surgical table was leaking oil.The procedure was completed successfully without delay.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the steris 4095 surgical table and confirmed evidence of an oil leak from the back left cylinder hydraulic hose.The technician made the necessary repairs to the back left cylinder hydraulic hose, tested the table, confirmed it to be operating to specification, and returned it to service.The device history record for the steris 4095 surgical table was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: STERIS
• Common Device Name: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23838003
• Report Number: 1043572-2025-00115
• Device Sequence Number: 18458479
• Product Code: FQO
• UDI-Device Identifier: 00724995195236
• UDI-Public: (01)00724995195236(11)250612
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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): 12/18/2025

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: 4095 SURIGICAL TABLE
• Device Catalogue Number: ST013911002
• 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: 11/19/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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