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

Model Number	4085 SURGICAL TABLE
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the 4085 surgical table and found that fluid intrusion within the table interior caused damage to the table power supply and electrical components which caused the reported event.The unit 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 ingress standards, and the normal fit of the 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 rating, 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 operator manual states, "some procedures performed on table mattresses or pads may involve excessive fluid exposure.Be sure to drape accordingly".Steris has offered in-service training on the proper use/operation of their 4085 surgical table, specifically on properly draping and/or fluid management practices, and also the need to ensure their table is properly sealed but the user facility has not yet responded.Steris service technician replaced the power supply and hand control, tested the table, confirmed it to be operational and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure their 4085 surgical table began to smoke.The patient was transferred to a different surgical table subsequently causing a procedure delay.The procedure was successfully completed; no report of injury.
Additional Manufacturer Narrative
Steris offered in-service training on the proper use/operation of their 4085 surgical table, specifically on properly draping and/or fluid management practices, and also the need to ensure their table is properly sealed; however, the user facility declined.

• 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: 16099025
• Report Number: 1043572-2023-00001
• Device Sequence Number: 6610042
• Product Code: FQO
• UDI-Device Identifier: 00724995154783
• UDI-Public: 00724995154783
• 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): 01/04/2023

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
• Device Model Number: 4085 SURGICAL TABLE
• Device Catalogue Number: ST013507
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2015
• 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