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

Model Number	5095 SURGICAL TABLE
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the table and found it to be operating properly.The table was tested, confirmed to be operating according to specification, and returned to service.Additionally, the technician discovered that the floor under the table was wet and did not allow the floor locks to engage properly, subsequently causing the reported event.The 5095 surgical table operator manual states, "1.Always check patient stability when patient is positioned.2.Do not place patient on this surgical table unless floor locks are engaged.3.Use extreme care when transferring patients to or from table." the 5095 surgical table subject of the reported event is not under steris service contract for maintenance activities; the user facility is responsible for all maintenance activities.While onsite the technician counseled user facility personnel on cleaning of the table's floor locks and ensuring the floor is dry prior to locking the table.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure their 5095 surgical table began to slide without being commanded to do so.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
Contrary to the initial report, there was no patient involvement as the event did not occur during a patient procedure.

• Brand Name: STERIS
• 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: 23946515
• Report Number: 1043572-2026-00002
• Device Sequence Number: 10648837
• Product Code: FQO
• UDI-Device Identifier: 00724995214074
• UDI-Public: (01)00724995214074(11)240507
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 01/02/2026

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: ST015210002SP
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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