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

Device Problem Unintended System Motion (1430)

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

Event Date 12/20/2021

Event Type  malfunction  

Event Description

The user facility reported that during a patient procedure their 3085 surgical table moved without being commanded to do so.The procedure was completed successfully.No report of injury or procedure delay.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the table and found that the table's column shrouds, and override control switches were damaged.Due to the damage, the override control switches remained in the activated position resulting in the reported event.The observed damage is indicative of user facility personnel 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 technician made the necessary repairs, tested the table, confirmed it to be operating according to specification, and returned it to service.A steris account manager offered in-service training on the proper use and operation of the 3085 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.

• Brand Name: 3085 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: 13508302
• MDR Text Key: 286599104
• Report Number: 1043572-2022-00013
• 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: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2002
• 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