MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5085 SURGICAL TABLE

Model Number	5085 Surgical Table
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that following a completed patient procedure their 5085 surgical table would not return to level position, instead the table moved further into trendelenburg position.The patient was removed from the surgical table onto a stretcher.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived on site to inspect the 5085 surgical table and found that the hydraulic hose for the leg cylinder was pinched between the tabletop and side rail.Additionally, the technician found that the bearing cover and shroud bellows were damaged.The 5085 surgical table was installed in 2020 and is not under steris service agreement for maintenance activities.The user facility's biomed department is responsible for all maintenance activities.The technician repaired the necessary components, tested the table, found it to be operating according to specification and returned it to service.A three-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: 5085 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: 16308711
• Report Number: 1043572-2023-00010
• Device Sequence Number: 6803436
• Product Code: FQO
• UDI-Device Identifier: 00724995154905
• UDI-Public: 00724995154905
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2023

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: 5085 Surgical Table
• Device Catalogue Number: ST014107
• 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: 01/13/2023
• Initial Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• 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