MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE

Model Number	4085 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	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that at the end of a patient procedure their 4085 surgical table was stuck in trendelenburg position as the table was not responding to the commands from the main or backup hand controls.No report of injury or procedure delay.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the 4085 surgical table and learned that a piece of equipment being stored on the base of the table was wedged between the shroud guard and the shroud which caused damage upon articulating the table down and into trendelenburg position.The shroud collapsed into the master control board and severed multiple electrical cables that ran to the power supply and the backup hand control resulting in the reported event.The 4085 surgical table operator manual states (1-3), "do not store items on table base.Doing so may result in equipment damage or inadvertent tabletop movement placing the patient and/or user at risk of injury." during manufacturing of the 4085 surgical table, a warning label is applied to the table's base cover.The warning label states, "warning do not store items on base personal injury hazard/equipment damage: storing items on table base may result in equipment damage causing inadvertent tabletop movement placing the patient and/or user at risk of personal injury.Do not step or store items on base!" the technician made the necessary repairs, tested the table, and returned it to service.A steris account manager offered in-service training on the proper use and function of the 4085 surgical table, specifically on ensuring items are not being stored on the base of the table.Steris is awaiting a response from the user facility, and a follow-up will be submitted when more information becomes available.
Additional Manufacturer Narrative
A steris account manager counseled user facility personnel on the proper use and function of the 4085 surgical table, specifically on ensuring items are not being stored on the base of the table.No additional issues have been reported.

• Brand Name: 4085 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 ; 4403927453
• MDR Report Key: 16855737
• Report Number: 1043572-2023-00095
• Device Sequence Number: 7566434
• Product Code: FQO
• UDI-Device Identifier: 00724995154813
• UDI-Public: 00724995154813
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/02/2023

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: 4085 SURGICAL TABLE
• Device Catalogue Number: ST013701
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2019
• 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