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

Model Number	4095 Surigical Table
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure user facility personnel unlocked their 4095 surgical table for repositioning, and the table began to tip.User facility personnel stabilized the table, and the procedure was completed successfully.No report of injury or procedure delay.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the 4095 surgical table and found it to be operating according to specification.No repairs were required, and the table was returned to service.The reported event is attributed to user error as user facility personnel should have centered and leveled the tabletop over the column prior to attempting to reposition the table as stated in the operator manual.The 4095 surgical table operator manual states (3.4-33), "table repositioning with patient aboard (not transport) if this surgical 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.3.Lower tabletop to lowest possible height.4.Ensure table path is clear of obstructions.5.One person must be at each end of tabletop.6.Release floor locks.7.If the table is moved with the patient aboard, apply only lateral force to reposition table.8.Do not push down on or lift tabletop while repositioning table.9.Once table is repositioned, lock table by engaging all floor locks." the operator manual further states (1.3-4), "warning - tipping hazard: the surgical table is not to be used to transport patients.With exception of slight repositioning, as detailed in the operating instructions, never disengage floor locks when patient is on table.Failure to heed this warning can result in injury to both the patient and the operating room staff." a steris account manager conducted in-service training with user facility personnel on the proper use and operation of the 4095 surgical table.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 ; 4403927453
• MDR Report Key: 16590535
• Report Number: 1043572-2023-00071
• Device Sequence Number: 11471723
• Product Code: FQO
• UDI-Device Identifier: 00724995195267
• UDI-Public: 00724995195267
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/22/2023

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: 4095 Surigical Table
• Device Catalogue Number: ST013910000
• 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: 02/24/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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