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

Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the 4095 surgical table.The technician tested the table by applying weight to the table and found that the table slowly drifted right which is indicative of the tilt cylinder requiring replacement.The technician replaced the tilt cylinder, tested the table, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure their 4095 surgical table drifted downward and to the right without being commanded to do so resulting in a procedure delay.The procedure was completed successfully.No report of injury.

• Brand Name: 4095 GENERAL 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: 13738977
• Report Number: 1043572-2022-00018
• Device Sequence Number: 4685296
• Product Code: FQO
• UDI-Device Identifier: 00724995195250
• UDI-Public: 00724995195250
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/11/2022

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: 02/10/2022
• Initial Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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