MAUDE Adverse Event Report: STERIS CORPORATION STERIS; SURGICAL TABLE

Model Number	4095 SURGICAL TABLE
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the 4095 surgical table and found no issues with the function or operation of the table.No repairs were required, and the table was returned to service.Based on the technician's inspection and discussion with user facility personnel, a root cause of the event could not be determined.The reported event could not be duplicated.A steris account manager offered in-service training on the proper use and operation of their 4095 surgical table and is pending a response.The device history record for the table subject of the reported event was reviewed and confirmed the table was manufactured to specifications; no abnormalities were noted.No additional issues have been reported.
Event or Problem Description
The user facility reported that the head and torso section to their 4095 surgical table "moved down" during a patient procedure.The patient was transferred to another surgical table resulting in a procedure delay.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris account manager offered in-service training on the proper use and operation of their 4095 surgical table; however, the user facility declined.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: 20694327
• Report Number: 1043572-2024-00073
• Device Sequence Number: 3850918
• Product Code: FQO
• UDI-Device Identifier: 00724995195281
• UDI-Public: (01)00724995195281(11)210202
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: 4095 SURGICAL TABLE
• Device Catalogue Number: ST013910002
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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