MAUDE Adverse Event Report: STERIS CORPORATION 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	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived on site to inspect the facility's 5095 surgical table and determined that the reported event was attributed to an oil leak from the hydraulic line which caused the small smoke.The technician reported the root cause of the oil leak was damage to the line caused by user facility personnel placing items on the table base.The 5095 general surgical table operator manual states, "warning - personal injury and/or equipment damage hazard: do not store items on surgical table base.Doing so may result in table damage or inadvertent tabletop movement placing the patient and/or user at risk of injury." the 5095 general surgical table operator manual states, "warning - do not store items on base- warning - personal injury and/or equipment damage hazard: storing items on table base may result in equipment damage causing inadvertent tabletop movement placing the patient and/or user at risk of personal injury.Do not step on or store items on base." a steris account manager completed in service training on (b)(6) 2024 with the customer on the warnings against placing/storing items on table base.The table has been removed from service to await further inspection by the steris service technician.A follow up mdr will be submitted once new information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure, a small amount of smoke appeared from the base of their 5095 surgical table while positioning a patient and noticed that there appeared to be a fluid leak.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris service technician made the necessary repairs to the 5095 surgical table, tested the table, confirmed it to be operating to specifications, and returned it back to service.No additional issues have been reported.

• Brand Name: STERIS
• Common Device Name: 5095 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
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20589508
• Report Number: 1043572-2024-00069
• Device Sequence Number: 15652657
• Product Code: FQO
• UDI-Device Identifier: 00724995195625
• UDI-Public: (01)00724995195625(11)230311
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/01/2024

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: 5095 SURGICAL TABLE
• Device Catalogue Number: ST015221000
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2023
• 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