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

Model Number	3085-R Surgical Table
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their 3085-r surgical table made a loud noise and became unstable.The procedure was completed successfully.No report of injury or procedure delay.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the table and found that the shrouds were damaged and bent along the column bracket.The observed damage is indicative of user facility personnel storing items on the base of the table.The 3085-r surgical table operator manual states, "safety precautions 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 counseled user facility personnel on the proper use and operation of the 3085 surgical table, specifically the importance of not storing items on the base of the table.The technician made the necessary repairs, tested the table, and returned to service.No additional issues have been reported.

• Brand Name: 3085-R SURGICAL TABLE
• Common Device Name: 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: 13971357
• Report Number: 1043572-2022-00022
• Device Sequence Number: 14571963
• Product Code: FQO
• UDI-Device Identifier: 00724995155025
• UDI-Public: (01)00724995155025
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

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
• Operator of Device: Health Professional
• Device Model Number: 3085-R Surgical Table
• Device Catalogue Number: RC4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown