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

Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, user facility personnel commanded the 4095 surgical table to lower in height via the hand control.When the "height down" button on the hand control was pressed, the surgical table appeared to go into reverse trendelenburg position.User facility personnel proceeded to press the "level" button and the table did not respond to commands and proceeded to lower in height followed by a loud "bang noise".The patient procedure was completed successfully, and no injuries were reported.
Additional Manufacturer Narrative
A steris service technician inspected the 4095 surgical table and found no issues with the function or operation with the table; the reported event was unable to be duplicated.The steris account manager discussed the reported event with user facility personnel and the evaluation results from the steris service technicians inspection of the 4095 surgical table.The steris account manager stated that the cause of the reported event may be attributed to an unnoted obstruction to the head section of the 4095 surgical table.The operator manual states (section 1.9), "warning - personal injury and/or equipment damage - failure to keep all personnel and equipment clear of the surgical table before actuating any inertia-driven or power-driven movement could result in table damage and/or personal injury." the steris account manager offered in-service training on the proper use and operation for the 4095 surgical table however, the user facility declined.The 4095 surgical 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: 17561528
• Report Number: 1043572-2023-00133
• Device Sequence Number: 17856215
• Product Code: FQO
• UDI-Device Identifier: 00724995195236
• UDI-Public: 00724995195236
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/16/2023

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: 07/20/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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