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

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the surgical table.During the technicians inspection, he found evidence of fluid intrusion within the base of the table, and no sealant around the base covers.The lack of sealant allowed fluid to enter the base of the table onto the electrical components resulting in the reported event.The table of the event was installed in 2018 and is not under steris agreement, the table is maintained by a third-party service provider.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.The 4085 surgical table operator manual states (section 5.10), "routine maintenance: 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 and is pending repairs.A steris account manager offered in-service training on properly draping the 4085 surgical table and on the importance of proper preventive maintenance, specifically resealing the base cover around the table following service or maintenance repairs.No additional issues have been reported.

Event Description

The user facility reported that prior to the start of a patient procedure their 4085 surgical table began to smoke.The fire department was dispatched.A procedure delay occurred as a patient was moved to a different table.The procedure was completed successfully.No report of injury.

Manufacturer Narrative

The technician made the necessary repairs, tested the table, confirmed it to be operating according to specifications, and returned it to service.A steris account manager performed in-service training on properly draping the 4085 surgical table and on the importance of proper preventive maintenance, specifically resealing the base cover around the table following service or maintenance repairs.No additional issues have been reported.

• Brand Name: 4085 SURGICAL TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• MDR Report Key: 11165045
• MDR Text Key: 227827940
• Report Number: 1043572-2021-00001
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1