MAUDE Adverse Event Report: STERIS CORPORATION 5095 SURGICAL TABLE

Model Number	5095 SURIGICAL TABLE
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure a patient slid towards the head section to their 5095 surgical table while the table was in the trendelenburg position.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and confirmed that the tabletop was sliding towards the head section of the table when positioned in trendelenburg.The slide motor was replaced and the table was tested, confirmed to be operating according to specification and returned to service.An exact cause could not be determined based on the technician's inspection; however, the event may be attributed to a misalignment of the motor gear with the tabletop rack.The device history record (dhr) was reviewed and confirmed that the device was manufactured to specifications.No additional issues have been reported.

• Brand Name: 5095 SURGICAL TABLE
• Common Device Name: 5095 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: 22525024
• Report Number: 1043572-2025-00066
• Device Sequence Number: 9231126
• Product Code: FQO
• UDI-Device Identifier: 00724995195649
• UDI-Public: (01)00724995195649(11)230201
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/16/2025

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 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: 06/16/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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