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	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event.The 4095 surgical table was inspected, and no issues were noted with the function or operation; the reported event was unable to be duplicated.The "cracking noise" heard by user facility personnel may be attributed to an object being underneath the table top during articulation and blocking the movement.The 4095 operator manual states, "warning, personal injury hazard - unanticipated table movement could cause patient injury.Patient must be secured to the table in accordance with recommended positioning practices.Patient injury may result if the operator of this table is not completely familiar with the controls for patient positioning and table operation." the operator manual further states, "tabletop articulation and patient positioning patient safety straps warning personal injury hazard - failure to keep the patient properly secured with the patient safety straps at all times could result in death or serious injury." steris offered in-service training on the proper use and operation for the 4095 surgical table and is awaiting a response.The 4095 surgical table was returned to service, and no additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure their 4095 surgical table went into trendelenburg position and tilted to the left without being commanded to do so.A "cracking noise" was heard and user facility personnel stated the patient "fell" from the table.The procedure was completed successfully, and no procedure delay or injury was reported.
Additional Manufacturer Narrative
Steris offered in-service training on the proper use and operation for the 4095 surgical table; however, the user facility declined.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 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: 22612380
• Report Number: 1043572-2025-00070
• Device Sequence Number: 5418789
• Product Code: FQO
• UDI-Device Identifier: 00724995195236
• UDI-Public: (01)00724995195236(11)250225
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/25/2025

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: 06/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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