MAUDE Adverse Event Report: STERIS CORPORATION STERIS; 4095 SURIGICAL TABLE

Model Number	4095 SURIGICAL TABLE
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived on-site to inspect the 4095 surgical table and found no issues with the function or operation of the table.The table was tested, confirmed to be operating to specifications, and returned to service.Based on the technician's inspection, the root cause is likely attributed to facility personnel not correctly centering the tabletop before attempting to transfer patient on to the surgical table.The 4095 surgical table operator manual (pg.1-1) states, "warning - tipping hazard: do not disengage floor locks when patient is on table." the 4095 surgical table operator manual (pg.1-2) also states, "the floor locks must be engaged at all times when a patient is on table." the 4095 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 worn or damaged accessory.Check installation before using any accessory - do not remove table leg section if patient is not properly positioned.Patient's torso and buttocks must be firmly held in place by table back and seat sections and legs supported by leg supports.Warning - personal injury and/or equipment damage hazard: - failure to perform periodic inspections of this surgical table could result in serious personal injury or equipment damage." the 4095 surgical table's operator manual further states, "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 on steris surgical table." a steris account manager offered in-service training on the proper use and operation of the 4095 surgical table and is currently pending a response.No additional issues have been reported.
Event or Problem Description
The user facility reported during a patient procedure, the leg section of the 4095 surgical table moved downwards without being commanded to do so.There was no report of injury or procedure delay.The procedure was completed successfully.
Additional Manufacturer Narrative
A steris account manager completed in-service training on (b)(6) 2024 with the customer on the proper use and operation of their 4095 surgical table.

• Brand Name: STERIS
• Common Device Name: 4095 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: 20694502
• Report Number: 1043572-2024-00072
• Device Sequence Number: 14391901
• Product Code: FQO
• UDI-Device Identifier: 00724995195236
• UDI-Public: (01)00724995195236(11)210325
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: 4095 SURIGICAL TABLE
• Device Catalogue Number: ST013911002
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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