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

Model Number	4095 SURGICAL TABLE
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, the right arm board to their 4095 surgical table "slid from the rail and fell" onto the patient.No report of injury.
Additional Manufacturer Narrative
A steris service technician contacted the user facility to obtain information regarding the reported event.User facility personnel stated that they are unable to locate the 4095 surgical table subject of the reported event.User facility personnel were also unable to provide information regarding details of the reported event.As the 4095 surgical table could not be located an evaluation by steris could not be performed and a root cause could not be determined.The device history record was reviewed and confirmed the table was manufactured to specifications; no abnormalities were noted.A follow-up report will be submitted should additional information become available.No additional issues have been reported.
Additional Manufacturer Narrative
Following the reported event, a steris service technician arrived onsite to inspect the 4095 surgical table and found no issues with the function or operation; the reported event was unable to be duplicated.The technician further inspected the armboard and table mounting side rail and confirmed the accessories to be operating according to specification.No repairs were required, and the table was returned to service.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 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
• MDR Report Key: 21943965
• Report Number: 1043572-2025-00046
• Device Sequence Number: 18279693
• Product Code: FQO
• UDI-Device Identifier: 00724995195212
• UDI-Public: (01)00724995195212(11)230307
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/01/2025

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: ST013911000
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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