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

Device Problem Device Tipped Over (2589)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the user facility's seven 3085 surgical tables.The technician tested the functions and articulations of the tables and found them to be operating properly.No repairs were required and the tables were returned to service.While onsite, the technician spoke with user facility personnel who stated that at the time of the reported events the patient is positioned with their weight distributed onto one side of the table column and base.They further stated that during patient transfer, the patient is rolled to one side of the tabletop.The positioning of the patient in combination with movement of the patient to one side of the tabletop allowed the table to become unstable and begin to tip.The reported events are attributed to user error as the employees should have positioned the patient to allow for proper table stability prior to patient transfer.The user facility is responsible for using appropriate patient positioning and movement practices.The 3085 surgical table operator manual states (1-2), "warning - instability hazard: stabilize table when transferring patient." the operator manual further states (2-4), "use extreme care when transferring patients to or from table." a steris account manager performed in-service training with facility personnel on the proper use and operation of the 3085 surgical table, specifically stabilizing the table prior to patient transfer.Facility personnel have adjusted their practices to ensure table stability by centering the patient over the column and base prior to patient transfer.No additional issues have been reported.

Event Description

The user facility reported that their 3085 surgical tables begin to tip during patient transfer at the end of urology procedures.No report of injury.

• 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: 9641714
• MDR Text Key: 209004967
• Report Number: 1043572-2020-00006
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/29/2020
• 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