MAUDE Adverse Event Report: STERIS Corporation STERIS; STERIS 4095 Surgical Table

Model Number	4095 Surgical Table
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported during a patient procedure with their steris 4095 surgical table that the patient slid towards the head section and the table ¿tilted slightly towards trendelenburg position¿.The patient was repositioned on the table, and the procedure was completed successfully without delay.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the steris 4095 surgical table and found no issues with the function or operation of the table.The unit was tested, confirmed to be operating according to specification, and returned to service.Upon further investigation, the technician learned that user facility personnel did not remove the head section prior to attaching the horseshoe adaptor accessory during pre-procedure set up, resulting in the reported event.The horseshoe adaptor accessory patient positioning instructions quick reference guide instructs the following to the user, ¿remove head section of the table.¿ the steris 4095 surgical table operator manual states, ¿positioning patient on table: ensure all accessories are properly installed and secured.¿ the steris 4095 surgical table operator manual additionally states the following warning to the user, ¿warning ¿ instability hazard states: possible patient or user injury, as well as table or accessory failure, may result from using steris table accessories for other than their stated purpose - or from using, on steris tables, accessories manufactured and sold by other companies.¿ while onsite the technician counseled user facility personnel on the proper use and operation with the steris 4095 surgical table, specifically, in properly using accessories while operating the table.The device history record was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.No additional issues have been reported.

• Brand Name: STERIS
• Common Device Name: STERIS 4095 Surgical 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 ; +1(440)259-7401
• MDR Report Key: 50147483
• Report Number: 1043572-2026-00081
• Device Sequence Number: 10603245
• Product Code: FQO
• UDI-Device Identifier: 00724995195236
• UDI-Public: (01)00724995195236(11)260127
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/05/2026

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: 07/09/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2026
• 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