MAUDE Adverse Event Report: STERIS CORPORATION STERIS; SURGICAL TABLE

Model Number	4085 SURIGICAL TABLE
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Fall (1848)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the column covers and seat section covers were bent as a result of the table tipping over.During the time of the reported event, the patient was positioned in reverse orientation and the table top was translated to the maximum distance towards the head end of the table.Additionally, the table leg section was not installed.This positioning caused the table to become unstable as all of the patient's weight was on one side of the table's support column resulting in the reported event.The 4085 surgical table operator manual states, "reverse patient orientation, definition: the headrest is attached to the leg section and the patient oriented with head on headrest." the technician provided a quote for the repairs.The unit subject of the reported event is not under steris service agreement for preventive maintenance activities; the user facility is responsible for all maintenance activities.A steris account manager offered in-service training to the user facility on proper use and operation of the 4085 surgical table, specifically on the correct patient positioning practice; however, the user facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure their 4085 surgical table tipped over and the patient fell off of the table.No report of injury or procedure delay.

• 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: 23843539
• Report Number: 1043572-2025-00116
• Device Sequence Number: 10030048
• Product Code: FQO
• UDI-Device Identifier: 00724995154783
• UDI-Public: (01)00724995154783(11)190909
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4085 SURIGICAL TABLE
• Device Catalogue Number: ST013507
• 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: 11/20/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2019
• 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