MAUDE Adverse Event Report: STERIS CORPORATION STERIS; 5095 SURGICAL TABLE

Model Number	5095 SURGICAL TABLE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the 5095 surgical table and found that the table would not level but would go into trendelenburg and appeared to have lost its calibration from testing the table which is attributed to the cause of the reported event.The technician recalibrated the table, tested the table, confirmed it to be operating according to specification, 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 5095 surgical table was not leveling when commanded to do so using the hand control.There was no report of injury or procedure delay.The procedure was completed successfully.

• Brand Name: STERIS
• Common Device Name: 5095 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
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20407731
• Report Number: 1043572-2024-00067
• Device Sequence Number: 3378914
• Product Code: FQO
• UDI-Device Identifier: 00724995195632
• UDI-Public: (01)00724995195632(11)230315
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/09/2024

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
• Device Model Number: 5095 SURGICAL TABLE
• Device Catalogue Number: ST015221000
• 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: 09/09/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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