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

Model Number	5095 SURGICAL TABLE
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the reported event a steris service technician arrived onsite to inspect the 5095 surgical table.The technician found that multiple third-party accessories including an additional extended headrest were installed on the table's dual articulating headrest.The patient's head was subsequently positioned upon the third-party headrest which shifted their torso onto the dual articulating headrest.This resulted in the reported event as the dual articulating headrest is only designed to support the patient's head or feet.The installation of the accessories with the dual articulating headrest was not in accordance with the intended use and design of the table.The 5095 surgical table operator manual states (section 1.7), "warning - instability hazard- possible patient or user injury, as well as surgical table or accessory failure, may result from using steris table accessories for other than their stated purpose or from using accessories manufactured and sold by other companies for use on steris surgical tables." the 5095 surgical table operator manual further states (section 1.9), warning - personal injury and/or equipment damage - table performance is validated as a system including components defined by steris in the operator and service manuals.Substitution of unauthorized components can potentially lead to personal injury, damage or premature failure of the product and result in a unit configuration that is inconsistent with the validated product.Steris warranty is void if components are used that are not approved.Do not use components that are not validated as part of this table.Dual-articulating headrest side rails support 100 ft-lb (135 n·m) maximum.The headrest end rail supports 50 ft-lb (67 n·m) maximum.Exceeding these limits could result in injury or equipment damage." the technician found no issues with the function or operation of the 5095 surgical table and returned the table to service.A steris account manager performed in-service training on the proper use and operation of the 5095 surgical table and the importance of properly installing third-party accessories.Following the steris technician's inspection and the steris account manager's in-service training, the user facility filed medwatch mw5169494 which steris received on may 2, 2025.No additional issues have been reported.
Event or Problem Description
The user facility reported that while a patient was positioned on their 5095 surgical table, the dual articulating headrest "collapsed" subsequently causing the patient to sustain an injury.User facility personnel elected to cancel the procedure.

• 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 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 22062143
• Report Number: 1043572-2025-00049
• Device Sequence Number: 7634883
• Product Code: FQO
• UDI-Device Identifier: 00724995195649
• UDI-Public: (01)00724995195649(11)240422
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 05/21/2025

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 SURGICAL TABLE
• Device Catalogue Number: ST015211002
• 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: 04/22/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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