MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY STERIS; 5095 SURGICAL TABLE

Model Number	5095 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	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the surgical table and found the table to be operating according to specification.There were no issues noted as all sensors and alarms were working correctly, and all articulations performed to specifications.On an abundance of caution, the technician did note a slow air leak on the right foot floor cylinder lock.The floor cylinder lock has been ordered and the surgical table is pending repairs.A steris account manager will offer in-service training on proper use and operation of the surgical table.A follow-up mdr will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure, facility personnel heard a loud noise, and their 5095 surgical table began to tilt to the left without being commanded to do so.The patient was transferred from the table to a stretcher resulting in a procedure delay.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
No repairs were made to the 5095 surgical table.Instead, the user facility opted to order a new surgical table.A steris technician counseled user facility personnel on the proper use and operation of the 5095 surgical table.No additional issues have been reported.
Additional Manufacturer Narrative
Steris received medwatch report (mw5154308) on may 13, 2024.Following receipt of the report, steris confirmed that an investigation for the reported event was previously completed and mdr # 1043572-2023-00169 for the event was submitted on december 20, 2023.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch report (mw5154308) that during a patient procedure, facility personnel heard a loud noise, and their 5095 surgical table lifted to the left without being commanded to do so.Facility staff stabilized the table by pressing it to the ground.The patient was transferred from the table to a stretcher resulting in a procedure delay.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• Brand Name: STERIS
• Common Device Name: 5095 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
• MDR Report Key: 18369637
• Report Number: 1043572-2023-00169
• Device Sequence Number: 12657396
• Product Code: FQO
• UDI-Device Identifier: 00724995214074
• UDI-Public: (01)00724995214074(11)221128(21)0431922049
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup
• Report Date (Section B): 12/20/2023

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: 5095 SURGICAL TABLE
• Device Catalogue Number: ST015210002SP
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/21/2023; Not provided; Not provided
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/26/2024; 06/12/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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