MAUDE Adverse Event Report: STERIS CORPORATION STERIS; LIGHTING SYSTEM

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	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their 5095 surgical table began to tip and a patient began to slide while the table was being put in trendelenburg position.The procedure was completed successfully and the patient did not fall off the table.No report of injury or procedure delay.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and found no issues with the function or operation of the table.The cause of the reported event is attributed to user facility personnel inadvertently contacting the hand control.The 5095 surgical table operator manual states, "failure to keep all personnel and equipment clear of the surgical table before actuating any inertia-driven or power-driven movement could result in table damage and/or personal injury." a steris account manager provided in-service training on the proper use and operation of the 5095 surgical table, specifically on proper hand control placement and handling.No additional issues have been reported.

• Brand Name: STERIS
• Common Device Name: LIGHTING SYSTEM
• 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 ; 4402597401
• MDR Report Key: 24914496
• Report Number: 1043572-2026-00035
• Device Sequence Number: 9241962
• Product Code: FQO
• UDI-Device Identifier: 00724995195649
• UDI-Public: (01)00724995195649(11)250125
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/17/2026

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: 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: 03/20/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2025
• 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