MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE

Model Number	4085 Surgical Table
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of the reported event, the patient was positioned with the table slide fully extended to the head end.User facility personnel disengaged the floor locks to change the orientation of the table when the table began to tip due to instability.The reported event is attributed to user error.The user facility personnel should not have unlocked the table floor locks prior to centering and leveling the tabletop with the patient over the column.The 4085 surgical table operator manual states (1-1), "warning - tipping hazard: do not disengage floor locks when patient is on table.However, if table needs to be repositioned within operating room with patient aboard, proceed as directed in section 2.2, patient positioning and weight limitation." the operator manual further states (2-3), "2.2 patient positioning and weight limitation.Table repositioning with patient - not for patient transport.If the table needs to be repositioned within the operating room with the patient aboard utilize the following procedure: 1.Ensure patient is properly secured.2.Center and level tabletop with patient over column." a steris service technician arrived onsite to inspect the table and confirmed the table to be operating according to specification.No repairs were required, and the table was returned to service.The user facility was counseled on the proper use and operation of the 4085 surgical table, specifically to ensure that the tabletop is leveled and centered prior to disengaging the floor locks.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure, user facility personnel disengaged the floor locks to their 4085 surgical table causing the table to begin to tip.The table was stabilized, and the procedure was completed successfully.No report of injury or procedure delay.

• Brand Name: 4085 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: 17267867
• Report Number: 1043572-2023-00123
• Device Sequence Number: 20803858
• Product Code: FQO
• UDI-Device Identifier: 00724995154776
• UDI-Public: 00724995154776
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2023

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
• Device Model Number: 4085 Surgical Table
• Device Catalogue Number: ST013501
• 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: 06/09/2023
• Initial Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2010
• 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