MAUDE Adverse Event Report: STERIS CORPORATION STERIS; 5085 SURGICAL TABLE

Model Number	5085 SURGICAL TABLE
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that with a patient positioned on their 5085 surgical table, the leg section and x-ray top dropped down causing a procedural delay.The procedure was completed successfully on the same table.No report of injury.
Additional Manufacturer Narrative
The steris service technician arrived onsite to inspect the table and found the possibility that the leg section of the table was never fully inserted correctly prior to use, which was completed by the user facility.The leg section was tested several times and stays mounted and locked when inserted correctly.The 5085 surgical table operator manual states (pg 1-2.) "when installing any table accessory, check for correct attachment and tighten securely (if appropriate).Do not use a worn or damaged accessory.Check installation before using any accessory." the 5085 surgical table operator manual states (pg 1-3) "warning - personal injury and/or equipment damage hazard: patient or operator injury may result if the operator of this table is not completely familiar with the controls for patient positioning and table operation." the table was tested, confirmed operational and returned to service.Steris account manager has counseled the customer on proper table installation and plans to have an additional in-service training session with additional staff members.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• Brand Name: STERIS
• Common Device Name: 5085 SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION; 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
• MDR Report Key: 18007287
• Report Number: 1043572-2023-00152
• Device Sequence Number: 6538032
• Product Code: FQO
• UDI-Device Identifier: 00724995154905
• UDI-Public: (01)00724995154905(11)211018(21)0427721005
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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