MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5095 SURGICAL TABLE

Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure the doctor raised the leg section of their 5095 surgical table causing the e-z lift beach chair to fall off the table and onto the floor.The patient was not injured.A procedure delay occurred as the patient was repositioned and the procedure was completed successfully.
Additional Manufacturer Narrative
A steris account manager spoke with user facility personnel and learned that the event was caused by user error.At the time of the event, the table was in reverse patient orientation and the doctor commanded the table to raise the back section.The doctor expected this command would raise the beach chair.However, as the table was in reverse orientation, this command caused the leg section receptacles to raise and push the beach chair off from where installed on the table.The 5095 surgical table operator manual states, "some surgeries (for example, shoulder injuries) require the patient to be in reverse positioning and the table to be operated in a reverse configuration.Press reverse orientation button on hand control and hold for two seconds, yellow led should light beside graphic representation of reverse orientation.Press reverse orientation button again and hold for two seconds to cancel reverse orientation function and green led lights beside graphic representation of normal orientation.When reverse orientation button is pressed, all other hand control commands (through the control system) note the new patient head position.Trendelenburg and lateral tilt movements and back and leg sections are automatically reversed." the account manager performed in-service training on proper use and operation of the 5095 surgical table.No additional issues have been reported.

• Brand Name: 5095 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: 19386168
• Report Number: 1043572-2024-00034
• Device Sequence Number: 12530819
• Product Code: FQO
• UDI-Device Identifier: 00724995195649
• UDI-Public: 00724995195649
• 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): 05/23/2024

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
• 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: 04/26/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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