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

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite and spoke with facility personnel regarding the reported event.Facility personnel stated that the procedure was fluid intensive, and fluid was being "dumped" onto the table.The technician inspected the table and observed evidence of fluid intrusion within the base of the table and evidence of smoke damage around the connectors.The fluid intrusion caused the electrical components within the base of the table to short resulting in the reported event.The technician replaced the power supply, tested the surgical table, confirmed it to be operating according to specifications, and returned it to service.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 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 technician counseled user facility personnel on the proper use and operation of the 4085 surgical table, specifically to ensure the table is properly draped and/or a fluid catchment device is utilized if the amount of fluid exceeds the ipx4 rating.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure their 4085 surgical table began to smoke.A procedure delay was reported as user facility personnel immediately turned off the table to allow the smoke to dissipate.Once the smoke had dissipated, the procedure was completed successfully.No injuries or inhalation/irritation were associated with the reported event.

• Brand Name: 4085 SURGICAL TABLE
• Type of Device: 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: 8634121
• MDR Text Key: 145919340
• Report Number: 1043572-2019-00037
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1