MAUDE Adverse Event Report: STERIS CORPORATION STERIS; SURGICAL TABLE

Model Number	4085 SURGICAL TABLE
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported during a procedure with their 4085 surgical table that the base of table was "smoking".The patient was transferred to another room resulting in a procedure delay; the procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the 4085 surgical table and found evidence of fluid intrusion under the column shrouds and onto the power supply of the table.The table has been removed from service and is pending repairs.The 4085 surgical table is designed to meet ipx4 fluid resistance standards, and the normal fit of the table covers, along with the rtv sealant that is applied, will prevent fluid intrusion.In the event the amount of fluid present during the procedure exceeds the ipx4 standard, it is the user facility's responsibility to ensure the table is properly draped and/ or a fluid catchment device is utilized to limit the amount of fluid that may come in contact with the 4085 surgical table.The 4085 surgical table operator manual states (5-3), "some procedures performed on table mattresses or pads may involve excessive fluid exposure.Be sure to drape accordingly." the operator manual further states, (5-10), "sealing table covers: whenever the table column cover assembly and/or table base cover are removed and then returned, the covers need sealed to prevent fluid intrusion to meet ipx4 requirements." while onsite the steris service technician conducted in-service training with user facility personnel on the proper use and operation of the 4085 surgical table, specifically, proper draping techniques during procedures.The device history record for the steris 4085 surgical table was reviewed and confirmed the unit was manufactured to specifications; no abnormalities were noted.A follow-up report will be submitted when additional information becomes available.

• Brand Name: STERIS
• Common Device Name: 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 ; 4402597401
• MDR Report Key: 24326436
• Report Number: 1043572-2026-00019
• Device Sequence Number: 9523547
• Product Code: FQO
• UDI-Device Identifier: 00724995154783
• UDI-Public: (01)00724995154783(11)191209
• 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,Followup
• Report Date (Section B): 02/12/2026

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: 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: 01/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2019
• 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