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

Model Number	4095 SURGICAL TABLE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the reported event, a steris service technician inspected the 4095 surgical table and observed damage to the column shroud covers.Damage to the column shroud covers is indicative of the table coming into contact with items that are being stored on the base of the table by user facility personnel.The operator manual states, "warning - personal injury and/or equipment damage hazard - do not store items on surgical table base.Doing so may result in equipment damage or inadvertent tabletop movement placing the patient and/or user at risk of injury." a warning label is also applied to the table base cover that states, "warning - do not store items on base.Personal injury hazard/equipment damage.Storing items on table base may result in equipment damage causing inadvertent tabletop movement placing the patient and/or user at risk of personal injury.Do not step on or store items on base!" the technician replaced the column shroud covers, tested the function and operation of the table and returned it to service.Steris offered in-service training on the proper use and operation for the 4095 surgical table and the importance of not storing items on the table base 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 4095 surgical table would not lower in height when commanded.User facility personnel elected to continue the procedure which was completed successfully.No report of injury.

• Brand Name: STERIS
• Common Device Name: 4095 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: 22529493
• Report Number: 1043572-2025-00067
• Device Sequence Number: 7487795
• Product Code: FQO
• UDI-Device Identifier: 00724995195281
• UDI-Public: (01)00724995195281(11)230511
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4095 SURGICAL TABLE
• Device Catalogue Number: ST013910002
• 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: 06/18/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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