MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4095 SURGICAL TABLE

Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the 4095 surgical table and found that table's floor locks were functioning correctly, and that there were no issues with the function or operation of the surgical table.Based on the description of the event and the technician's inspection, it is likely that the reported event was caused by an obstruction stored below or around the table.The table may lift from the floor as described in the reported event should an object obstruct the tabletop from being lowered when commanded.The 4095 surgical table operator manual states (pg.18), "warning-personal injury and/or equipment damage hazard: failure to keep all personnel and equipment clear of the surgical table before actuating any inertia-driven or power-driven movement could result in table damage and/or personal injury." a steris account manager will offer in-service training on the proper use and operation of the 4095 surgical table, specifically, to ensure the table is clear of any potential obstruction to table movements.
Event or Problem Description
The user facility reported that during a patient procedure their 4095 surgical table was found tipped towards the head end and the foot end of the table had lifted off the floor.The procedure was completed successfully.No report of injury or procedure delay.
Additional Manufacturer Narrative
A steris account manager offered in-service training on the proper use and operation of the 4095 surgical table; however, the user facility declined.No additional issues have been reported.

• Brand Name: 4095 SURGICAL TABLE
• Common Device Name: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19020966
• Report Number: 1043572-2024-00018
• Device Sequence Number: 15462017
• Product Code: FQO
• UDI-Device Identifier: 00724995195281
• UDI-Public: 00724995195281
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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