MAUDE Adverse Event Report: STERIS CORPORATION STERIS; SURGICAL TABLE

Model Number	4085 SURGICAL TABLE
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the table and found no issues with the function or operation of the table.The table was tested, confirmed to be operating according to specification, and returned to service.The cause of the reported event is attributed to user facility personnel not properly centering the patient over the tabletop column prior to unlocking and repositioning the table.The 4085 surgical table operator manual states, "if this surgical table needs to be repositioned within the operating room with the patient aboard, utilize the following procedure: ensure patient is properly secured.Center and level tabletop with patient over column.Lower tabletop to lowest possible height.Ensure table path is clear of obstructions.One person must be at each end of tabletop.Release floor locks.If the table is moved with the patient aboard, apply only lateral force to reposition table.Do not push down on or lift tabletop while repositioning table.Once table is repositioned, lock table by engaging all floor locks".The table subject of the reported event is not under steris service agreement for maintenance; the user facility is responsible for all maintenance activities.A steris account manager offered in-service training on the proper use and operation of the 4085 surgical table and is awaiting a response from the user facility.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure their 4085 surgical table began to tilt while in the supine position and the patient slid forward.The procedure was cancelled, and the patient received a ct scan and is doing well.No report of injury.
Additional Manufacturer Narrative
A steris account manager provided in-service training on the proper use and operation of the 4085 surgical table, specifically on properly centering the patient over the tabletop column prior to unlocking and repositioning the table.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: 23850082
• Report Number: 1043572-2025-00121
• Device Sequence Number: 21321655
• Product Code: FQO
• UDI-Device Identifier: 00724995154813
• UDI-Public: (01)00724995154813(11)160115
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/19/2025

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: 4085 SURGICAL TABLE
• Device Catalogue Number: ST013701
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2016
• 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