MAUDE Adverse Event Report: STERIS CORPORATION STERIS; 4095 SURIGICAL TABLE

Model Number	4095 SURGICAL TABLE
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the 4095 surgical table and found the unit to be operating according to specification.No issues with the function or operation of the table were found and the unit was returned to service.While onsite, the steris clinical support representative spoke with user facility personnel who stated at the time of the reported event the patient was positioned in reverse orientation with the tabletop fully extended toward the head end.Additionally, the user facility used a headrest extender incompatible with the steris 4095 surgical table.This combination caused the table to become unstable as all the patient's weight was on one side of the table's support column resulting in the reported event.The 4095 surgical table operator manual states, "warning - instability hazard: possible patient or user injury, as well as surgical table or accessory failure, may result from using steris table accessories for other than their stated purpose - or from using accessories manufactured and sold by other companies for use on steris surgical tables." the steris surgical table patient positioning guide included with every 4095 surgical table sold states, "never add additional accessories to the table to extend the table platform further from the column (unless you have consulted with steris).This may cause table instability." a steris clinical support representative performed in-service training with user facility personnel on the proper use and operation of the 4095 surgical table, specifically proper table configuration and patient positioning.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure their 4095 surgical table tipped over.The patient was transferred to a different table, and the procedure was completed successfully following a short delay.No report of injury.

• Brand Name: STERIS
• Common Device Name: 4095 SURIGICAL TABLE
• 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: 25034664
• Report Number: 1043572-2026-00042
• Device Sequence Number: 9323485
• Product Code: FQO
• UDI-Device Identifier: 00724995195236
• UDI-Public: (01)00724995195236(11)251211
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/29/2026

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: 4095 SURGICAL TABLE
• Device Catalogue Number: ST013911002
• 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: 03/30/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2025
• 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