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

Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their 4095 surgical table would not respond to hand control commands during a patient procedure.The procedure was completed with the table as positioned.No report of injury or procedure delay.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the table and was able to reproduce the reported event.Upon inspection, the technician found that the tables energy chain and bracket were both bent.As a result of the bending, the tables hydraulic hoses became pinched causing damage to the cables.The steris service technician ordered the tables replacement parts.A follow up mdr will be submitted upon repair.
Additional Manufacturer Narrative
The technician made the necessary repairs to the 4095 surgical table subject of the reported event.The unit was then tested, confirmed to be operating according to specifications, and returned to service.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
• MDR Report Key: 17445406
• Report Number: 1043572-2023-00129
• Device Sequence Number: 19559626
• Product Code: FQO
• UDI-Device Identifier: 00724995195236
• UDI-Public: 00724995195236
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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