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	11/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the 4085 surgical table and found dried fluid within the table backup hand control drawer leading down to the table power supply and there was evidence of fluid intrusion within the base of the table.The technician attributed the root cause of the reported event to an electrical component failure internal to the power supply due to fluid intrusion.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 the table but the user facility has not yet responded.The table remains out of service pending repairs.
Event or Problem Description
The user facility reported that during a patient procedure their 4085 surgical table began emitting smoke due to fluid intrusion.The table was unplugged while facility personnel waited for the smoking to stop resulting in a procedure delay.Once the smoking stopped the user facility elected to continue the procedure; the procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris service technician performed the necessary repairs, tested the table, confirmed it to be operating according to specification and returned it to service.Steris counseled the user facility on the proper use/operation of their 4085 surgical table, specifically on properly draping 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: 16033393
• Report Number: 1043572-2022-00092
• Device Sequence Number: 14821888
• Product Code: FQO
• UDI-Device Identifier: 00724995154783
• UDI-Public: 00724995154783
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 12/22/2022

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: 11/28/2022
• Supplement Date Received by Manufacturer: 11/28/2022; 11/28/2022
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/27/2023; 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2018
• 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