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

Device Problems Unintended Movement (3026); Key or Button Unresponsive/not Working (4063)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Following the reported event, user facility personnel removed the table from service.A steris service technician arrived onsite to inspect the table and found that the table's column shrouds were damaged which caused the outer shroud layer to contact the table's override control switches resulting in the reported event.The table was installed in 2006 making it approximately 14 years old and is not under steris service agreement; the user facility is responsible for all maintenance activities.The damage to the column shrouds was caused by storing items on the base of the table.The 3085 sp surgical table operator manual states (1-3), "warning - personal injury and/or equipment damage hazard: storing items on table base may result in equipment damage causing inadvertent tabletop movement placing patient and/or user at risk of personal injury.Do not use table base for storage." the user facility was provided a quote for the repairs to the table.A steris account manager offered in-service training on the proper use and operation of the 3085 sp surgical table, specifically the importance of not storing items on the base of the table; however, the user facility declined.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure the leg section of their 3085 surgical table moved upward without being commanded to do so.Facility personnel commanded the leg section to lower on the hand control and the table would not respond to the commanded movement.The patient was transferred to a different surgical table resulting in a procedure delay; the procedure was completed successfully.No report of injury.

Manufacturer Narrative

During a periodic review of the maude database, steris became aware of user facility medwatch report # mw5098025 on 1/13/2021.We reviewed our records and confirmed the event described in the user facility medwatch is the same event which was reported in mdr 1043572-2020-00060.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: 10977498
• MDR Text Key: 221266329
• Report Number: 1043572-2020-00060
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• 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: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1