MAUDE Adverse Event Report: STERIS CORPORATION STERIS; 5095 SURIGICAL TABLE

Model Number	5095 SURIGICAL TABLE
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the table and concluded that the reported event was caused by the facility's failure to engage the locking knobs to secure the headrest assembly to the table.The 5095 general surgical table operator manual states, "warning - personal injury hazard: when installing any table accessory, check for correct attachment and tighten securely (if appropriate).Do not use a worn or damaged accessory.Before using any accessory, ensure it has been installed properly." the 5095 general surgical table operator manual states, "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 technician counseled user facility personnel on the importance of securely engaging the locking knobs to secure the headrest assembly.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee obtained a bruise after the head section fell from their 5095 surgical table and landed on the employee's foot.Medical treatment was administered with an ice pack and the employee returned to work.

• Brand Name: STERIS
• Common Device Name: 5095 SURIGICAL 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: 21440983
• Report Number: 1043572-2025-00014
• Device Sequence Number: 17294730
• Product Code: FQO
• UDI-Device Identifier: 00724995195694
• UDI-Public: (01)00724995195694(11)240718
• 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): 02/14/2025

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: 5095 SURIGICAL TABLE
• Device Catalogue Number: ST015210002
• 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: 01/16/2025
• Initial Report FDA Received Date: 02/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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