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

Model Number	4085 SURGICAL TABLE
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the table and found damage to the base of the table and shroud covers.The technician also found evidence of fluid intrusion within the power supply and that the rtv sealant required replacement.The 4085 surgical table is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.The 4085 surgical table is designed to meet ipx4 fluid resistance standards, and the normal fit of the table covers, along with the rtv sealant that is applied, will prevent fluid intrusion.In the event the amount of fluid present during the procedure exceeds the ipx4 standard, it is the user facility's responsibility to ensure the table is properly draped and/ or a fluid catchment device is utilized to limit the amount of fluid that may come in contact with the 4085 surgical table.The 4085 surgical table operator manual states (5-3), "some procedures performed on table mattresses or pads may involve excessive fluid exposure.Be sure to drape accordingly." the operator manual further states, (5-10), "sealing table covers: whenever the table column cover assembly and/or table base cover are removed and then returned, the covers need sealed to prevent fluid intrusion to meet ipx4 requirements." the table has been removed from service as it is pending repairs.Steris offered in-service training on the proper use and operation of the 4085 surgical table, specifically on proper draping and/or fluid management practices, as well as the importance of not storing items on the base of the table, and the importance of following proper preventive maintenance activities.Steris is currently awaiting a response from the user facility.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their 4085 surgical table was emitting smoke.A patient was not on the table at the time of the reported event.No report of injury.Report of procedure delays.
Additional Manufacturer Narrative
The technician replaced the power supply and made the necessary repairs to the shrouds and the base of the table.The technician tested the table, confirmed it to be operating according to specification, and returned it to service.A steris surgical services representative conducted in-service training on the proper use and operation of the 4085 surgical table, specifically on proper draping and/or fluid management practices, as well as the importance of not storing items on the base of the table, and the importance of following proper preventive maintenance activities.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: 16590608
• Report Number: 1043572-2023-00072
• Device Sequence Number: 5088348
• Product Code: FQO
• UDI-Device Identifier: 00724995154813
• UDI-Public: 00724995154813
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/22/2023

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: 02/24/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2018
• 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