MAUDE Adverse Event Report: STERIS Corporation Surgigraphic; SurgiGraphic 6000 Image Guided Surgical Table

Model Number	Surgigraphic 6000 Table
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction

• 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; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50252596
• Report Number: 1043572-2026-00083
• Device Sequence Number: 13304318
• Product Code: GDC
• UDI-Device Identifier: 00724995155247
• UDI-Public: (01)00724995155247(11)170828
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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: 07/20/2026
• Initial Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 08/28/2017
• 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