MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3085 SP SURGICAL TABLE

Device Problem Unintended System Motion (1430)

Patient Problem Insufficient Information (4580)

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 3085 sp surgical table and found that the override switch board within the table had shorted.During the technicians inspection, he observed an opening in the bellows which allowed for fluid intrusion to enter the table causing the override switch to short.The reported event is attributed to facility personnel not properly resealing the table after maintenance activities to prevent fluid intrusion.The table of the event is not under steris agreement, the table is maintained by a third-party service provider.The 3085 sp 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 3085 sp surgical table operator manual (1-2) states, "warning - personal injury and/or equipment damage hazard: safe and reliable operation of this equipment requires regularly scheduled preventive maintenance, in addition to the faithful performance of routine maintenance.Contact steris to schedule preventive maintenance." the 3085 sp surgical table preventive maintenance checklist states to perform the following twice annually, "5.1 secure all covers and shrouds.Apply rtv sealer to meet ipx4 requirements." 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 offered in-service on proper maintenance, specifically ensuring the table is properly resealed to prevent fluid intrusion; steris is awaiting the user facility's response.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that during a patient procedure their 3085 surgical table went into a reverse trendelenburg position without being commanded to do so.User facility personnel stabilized the table and secured the patient.The patient was transferred to a different table resulting in a procedure delay.The procedure was completed successfully.No report of injury.

Manufacturer Narrative

A steris account manager offered in-service training on proper maintenance, specifically ensuring the table is properly resealed to prevent fluid intrusion; however, the user facility declined.No additional issues have been reported.

• Brand Name: 3085 SP SURGICAL TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• MDR Report Key: 11864056
• MDR Text Key: 255127186
• Report Number: 1043572-2021-00037
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1