MAUDE Adverse Event Report: STERIS CORPORATION SURGIGRAPHIC; SURGIGRAPHIC 6000 IMAGE GUIDED SURGICAL TABLE

Model Number	SURGIGRAPHIC 6000 TABLE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the table and found that the lateral tilt sensor assembly was not functioning properly resulting in the reported event.The table has been removed from service as it is pending repairs.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure, their surgigraphic 6000 image guided surgical table would not move in response to commands.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The technician replaced the lateral tilt sensor assembly, calibrated the table control board, tested the table, confirmed it to be operating according to specification, and returned it to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• Brand Name: SURGIGRAPHIC
• Common Device Name: SURGIGRAPHIC 6000 IMAGE GUIDED SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION; 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: 17950943
• Report Number: 1043572-2023-00150
• Device Sequence Number: 12644971
• Product Code: GDC
• UDI-Device Identifier: 00724995155247
• UDI-Public: (01)00724995155247(11)210616(21)00724995155247
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/17/2023

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
• Device Model Number: SURGIGRAPHIC 6000 TABLE
• Device Catalogue Number: TA01
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 09/14/2023; Not provided
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 10/25/2023; 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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