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

Model Number	4095 SURGICAL TABLE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility personnel stated that the 4095 surgical table was in reverse orientation at the time of the reported event.A featherweight leg section was attached to the table and the head section was attached to the featherweight leg section.During the patient's transfer, weight was applied to the head section subsequently causing the head section to fall under the patient's weight.The tabletop should be centered prior to transfer as the head and leg sections are not designed to support full body weight.A steris service technician inspected the function and operation of the 4095 surgical table and confirmed the device was operating to specifications; no repairs were conducted.The featherweight leg section was removed from service.The 4095 surgical table's operator manual states, "tabletop articulation and patient positioning - states: center tabletop over column before transferring patient on or off of surgical table.- positioning patient on table - item 7.Do not exceed 350 lb (159 kg) on the leg section.Leg section is not designed to support full body weight." the technician counseled user facility personnel on the importance of following proper patient loading and transfer procedures.The 4095 surgical table was returned to service, and no additional issues have been reported.
Event or Problem Description
The user facility reported that following a patient procedure, they were transferring a patient from their 4095 surgical table onto a stretcher and when weight was applied to the table's head section it "gave way" and fell.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: 22529507
• Report Number: 1043572-2025-00068
• Device Sequence Number: 7488272
• Product Code: FQO
• UDI-Device Identifier: 00724995195236
• UDI-Public: (01)00724995195236(11)240905
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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?: 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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