MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4095 SURGICAL TABLE

Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that while utilizing a third-party beach chair accessory with their 4095 surgical table during a patient procedure, the table became unstable subsequently causing the table to lift off the floor at one end.The procedure was completed successfully, and no injuries were reported.
Additional Manufacturer Narrative
Through follow-up with user facility personnel, a steris surgical specialist learned that prior to the reported event, the 4095 surgical table's headrest assembly was removed, and the third-party beach chair accessory (arthrex lift-assist beach chair) was installed onto the table's back section.User facility personnel did not have the third-party beach chair accessory installed correctly onto the 4095 surgical table, as the accessory should be installed by either removal or lowering of the table's leg section and installing the accessory on the seat section of the table.During the time of the reported event, the 4095 tabletop was slid the maximum distance towards the head end of the table.The configuration of the 4095 surgical table and beach chair accessory was causing the patient's body mass to go beyond the table support column subsequently causing the table to become unstable.The 4095 surgical table's 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." "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 performed in-service training on the proper use and operation of the 4095 surgical table and the importance of properly installing accessories.A steris service technician inspected the 4095 surgical table and found no issues with the function or operation.The table was returned to service and no additional issues have been reported.

• Brand Name: 4095 SURGICAL TABLE
• Common Device Name: 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: 17835856
• Report Number: 1043572-2023-00143
• Device Sequence Number: 18085235
• Product Code: FQO
• UDI-Device Identifier: 00724995195250
• UDI-Public: 00724995195250
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/28/2023

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
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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