MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. ORT200; OPERATING ROOM TABLE

Model Number	ORT200
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is attempting to arrange a user facility visit through the user facility's third party servicer in order to investigate and address the reported device malfunction in the operating room table.No additional patient or demographic information was provided.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Customer reported that during a laser ablation procedure, monteris staff and customer staff noticed the initial probe scan and post ablation scans do not align, indicating suspected operating room table drift.It was reported no additional medications, monitoring or unplanned procedural steps were required and the procedure was successful.This mdr is being submitted based on manufacturer awareness of a second case in which the alleged table drift occurred as captured in mdr 3010326005-2024-00010.
Additional Manufacturer Narrative
The manufacturer investigated and addressed the reported event at the customer site after gaining access to the operating room table.The hydraulic fluid was flushed and subsequent drift testing passed requirements.The probable cause of the event was particulate formation in the hydraulic fluid from system component wear over time.Further diagnostics or component repairs were declined.No patient or procedural impact was reported.This report also encompasses udi related data quality updates to match brand name and udi with gudid data.

• Brand Name: ORT200
• Common Device Name: OPERATING ROOM TABLE
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: paul campbell ; 1230 chaska creek way; suite 100; chaska, MN 55318 ; 7632036344
• MDR Report Key: 20218564
• Report Number: 3010326005-2024-00011
• Device Sequence Number: 7858207
• Product Code: KXJ
• UDI-Device Identifier: 00857534006738
• UDI-Public: (01)00857534006738(11)20110618
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: ORT200
• Device Catalogue Number: 113821-600
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2011
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown