MAUDE Adverse Event Report: STERIS CORPORATION STERIS; 4085 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	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the surgical table and found no issues with the function or operation of the table.The reported event could not be duplicated.Upon further discussion with user facility personnel, it is likely that the reported event was caused by an obstruction stored below or around the table.The table may lift from the floor and tip over as described in the reported event should an object obstruct the tabletop from being lowered when commanded.The 4085 surgical table operator manual states (pg.23), "warning-personal injury and/or equipment damage hazard: 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 performed in-service training on the proper use and function of the 4085 surgical table, specifically on ensuring that other pieces of equipment are clear of the table.No additional issues have been reported.
Event or Problem Description
The user facility reported following the patient procedure during patient transfer, their 4085 surgical table was being lowered in height and "tipped over." no report of injury or procedure delay.

• Brand Name: STERIS
• Common Device Name: 4085 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: 23008038
• Report Number: 1043572-2025-00083
• Device Sequence Number: 13389025
• Product Code: FQO
• UDI-Device Identifier: 00724995154783
• UDI-Public: (01)00724995154783(11)171016
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/09/2025

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: 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: 08/11/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2017
• 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