MAUDE Adverse Event Report: STERIS CORPORATION STERIS; SURGICAL TABLE

Model Number	4085 SURGICAL TABLE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their e-z lift beach chair accessory had detached and fell from their 4085 surgical table during a patient procedure.No report of injury or delay.
Additional Manufacturer Narrative
A steris service technician arrived on site to inspect the reported device.The customer informed the technician that while the patient was on the table, the attendant tried to raise the patient's legs without configuring the table hand control for the reverse patient orientation operation.This resulted in the table leg section receptacles moving upward in response to the command which pushed and detached the e-z beach chair accessory.The patient fell back as the accessory fell off.The technician further examined the table and found it to be undamaged and operational.The e-z beach chair accessory had sustained damaged and was removed from service pending a replacement.The 4085 surgical table operator manual states: "reverse patient orientation, definition: the headrest is attached to the leg section and the patient oriented with head on headrest.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 technician counseled user facility personnel on the use and operation of the 4085 surgical table as it relates to the use of the e-z beach chair accessory.No additional issues have been reported.

• Brand Name: STERIS
• Common Device Name: 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: 19949770
• Report Number: 1043572-2024-00055
• Device Sequence Number: 12986207
• Product Code: FQO
• UDI-Device Identifier: 00724995154783
• UDI-Public: (01)00724995154783
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/09/2024

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: 4085 SURGICAL TABLE
• Device Catalogue Number: ST013507
• 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: 07/12/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2019
• 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