MAUDE Adverse Event Report: STERIS CORPORATION STERIS; 4085 SURGICAL TABLE

Model Number	4085 SURGICAL TABLE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the table and found no issue with the function or operation of the table.The reported event could not be duplicated.Based on the description of the event and the technician's inspection, 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 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 powerdriven movement could result in table damage and/or personal injury." a steris account manager offered in-service training on the proper use and function of the 4085 surgical table; 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 was tipped toward the foot end and the head end of the table had lifted off the floor.The procedure was completed successfully.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 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
• MDR Report Key: 21472506
• Report Number: 1043572-2025-00021
• Device Sequence Number: 3652589
• Product Code: FQO
• UDI-Device Identifier: 00724995154783
• UDI-Public: (01)00724995154783(11)200415
• 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): 02/26/2025

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: 01/27/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2020
• 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