MAUDE Adverse Event Report: STERIS CORPORATION STERIS; 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	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch report #(b)(4) that a loud noise was heard during patient transfer from an icu bed.The bottom two "pieces" of the steris 4095 surgical table fell to the floor causing the patient's legs to drop.An employee held the patient's legs and transferred them back to the icu bed.No report of injury.
Additional Manufacturer Narrative
Following receipt of the medwatch, steris contacted the user facility and learned that the user facility's biomed department inspected the table at the time of the event and found that the leg accessory for the table was broken.The user facility made the necessary repairs and returned the table to service.Additionally, steris learned that the broken leg accessory had already been discarded by the user facility and is not available to be returned to steris for evaluation.The user facility was unable to provide the serial number of the discarded leg accessory.Without an evaluation of the broken leg accessory, the cause of the reported event cannot be determined.A steris service technician offered to perform an inspection of the surgical table; however, the user facility declined.The surgical table is not under steris service agreement for preventive maintenance activities; the user facility is responsible for all maintenance activities.No additional issues have been reported.

• 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: 24004104
• Report Number: 1043572-2026-00003
• Device Sequence Number: 10509476
• Product Code: FQO
• UDI-Device Identifier: 00724995195236
• UDI-Public: (01)00724995195236(11)240304
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 01/08/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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