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

Model Number	STERIS
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During follow up with user facility personnel, it was disclosed that a nurse present at the time of the reported event was hit by the armboard when the table moved.The nurse applied ice and took over the counter pain reliever.User facility personnel present at the time of the reported event stated that the table unlocked while the hand control was stored between the tabletop and the x-ray top.At the conclusion of the procedure, the table was commanded to level however, a "loud snap" was heard followed by the table going into reverse trendelenburg.The noise heard by user facility personnel can be indicative of the table contacting items stored on the table base during movement.The hand control subject of the reported event was also indicating the battery level to be low.A steris service technician inspected the 4095 surgical table and was unable to duplicate the reported event.The technician did observe damage to the hand control cord and the clip on the back of the hand control to be missing.The table's column shrouds also exhibited damage.The user facility declined repairs to be completed by steris.The 4095 surgical table is not under a steris service contract.The user facility is responsible for all service and maintenance activities.Steris offered in-service training on the proper use and operation of the 4095 surgical table, specifically not storing items on the base of the table and the importance of proper handling of the hand control 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 unlocked and lowered in height without being commanded to do so.The patient was transferred to another table, and the procedure was completed successfully.
Additional Manufacturer Narrative
On december 3, 2025, steris received medwatch mw5178876.During our investigation it was determined that this medwatch is associated with medical device report (mdr) 1043572-2025-00097 that was submitted on october 31, 2025.It should be noted that steris is submitting a follow-up mdr solely due to the receipt of the user facility medwatch report which is in accordance with our procedures.No additional issues have been reported.

• 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: 23438807
• Report Number: 1043572-2025-00097
• Device Sequence Number: 17333099
• Product Code: FQO
• UDI-Device Identifier: 00724995195236
• UDI-Public: (01)00724995195236(11)220823
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/31/2025

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: STERIS
• Device Catalogue Number: 4095 SURGICAL TABLE
• Device Lot Number: (21)0421422059
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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