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

Model Number	5085 SURGICAL TABLE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the table and found no issues with the function of the table.The table was returned to service.While onsite, the technician learned that the patient was not properly restrained to the table by user facility personnel, subsequently causing the reported event.The 5085 surgical table operator manual states, "warning - personal injury hazard: failure to keep the patient properly secured with the patient safety straps at all times could result in death or serious injury.Adjust the patient safety straps so that they restrain the patient according to currently accepted patient restraining practices, keeping in mind trendelenburg/reverse trendelenburg, back, lateral tilt and height adjustment." in addition, the technician counseled user facility personnel on the proper use and operation of the 5085 surgical table, specifically on properly restraining patients to the table.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure a patient slid down their 5085 surgical table while the table was in the trendelenburg position.The patient was repositioned on the table and the procedure was completed successfully.No report of injury.

• 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; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 22117491
• Report Number: 1043572-2025-00051
• Device Sequence Number: 17935968
• Product Code: FQO
• UDI-Device Identifier: 00724995154905
• UDI-Public: (01)00724995154905(11)200612
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/30/2025

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: 05/02/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2020
• 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