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

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

Both a steris service technician and the user facility's biomed department inspected the 3085 sp surgical table and found no issue with the function or operation of the surgical table or accessories.No repairs were required, and the table was returned to service.The 3085 sp surgical table was installed in 2002 making the unit approximately 18 years old and is not under steris service agreement for maintenance activities.The facility's biomed department is responsible for all maintenance activities.A steris account manager has offered in-service training on the proper use and operation of the 3085 sp surgical table.No additional issues have been reported.

Event Description

The user facility reported that their 3085 sp surgical table made an uncommanded table movement during a patient procedure.No report of injury or procedure delay.The procedure was completed successfully.

Manufacturer Narrative

A steris account manager provided the user facility with in-service training on the proper use and operation of the 3085 sp surgical table.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
• MDR Report Key: 9759113
• MDR Text Key: 191674234
• Report Number: 1043572-2020-00012
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 01/27/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1