MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT400 OPERATING ROOM TABLE

Model Number	ORT 400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation has been completed.
Event or Problem Description
It was reported that during a magnetic resonance-guided litt procedure, the area targeted for ablation appeared, prior to ablation, to be 4.5 mm to 8 mm off target.The case was completed after noting the possible image distortion issue and no patient impact or consequence was reported.
Additional Manufacturer Narrative
The root cause of this event was traced to user error of incorrect localizer settings; the first localizer settings were not zeroed out which led to an error impacting patient registration.The phase shift was reported to be observed prior to ablation therapy, after which coordinate adjustments were made and the procedure continued without further impact.A device malfunction was not identified during the investigation.

• Brand Name: IMRIS ORT400 OPERATING ROOM TABLE
• Common Device Name: OPERATING ROOM TABLE
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer Contact: paul campbell ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 12637520
• Report Number: 3010326005-2021-00012
• Device Sequence Number: 13826643
• Product Code: KXJ
• UDI-Device Identifier: 00857534006691
• UDI-Public: (01)00857534006691(11)210715
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: ORT 400
• Device Catalogue Number: 119493-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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