MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. VISIUS SURGICAL THEATRE ICT; X-RAY SYSTEM, DIAGNOSTIC, COMPUTED TOMOGRAPHY, FULL-BODY

Model Number	115219-000
Medical Device Problem Codes	Device Slipped (1584); Device Dislodged or Dislocated (2923); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer inspected the intra-operative ct system at the customer site and found no obvious signs of component malfunction, wear, or damage that may have caused or contributed to the reported event.System movement from home to scanning position was exercised multiple times during this inspection.Further investigation is in process and a follow-up report will be submitted with any updated findings.
Event or Problem Description
During a research, animal study case, the ict cable carrier linkages were discovered to have slipped off of the overhead support tray and remained suspended.This was observed by the user facility staff in between study case scans and was reported to occur during normal system movement.Scanning was reportedly not interrupted and no repeat scanning was required.The user facility staff lifted the cable carrier linkages back onto the support tray and completed the animal study case; a delay of 30 minutes was incurred during this time.After case completion the ct system was able to be moved back to the home position.
Additional Manufacturer Narrative
The root cause was established and relates to device design.The cable carrier (energy chain) travels on cieling-mounted support trays during ct imager movement between its home position and imaging position in the operating room.At the fixed ends of the cable carrier, the cable carrier is retained and unable to track off the support tray; however, in the straight sections of the support tray the tolerance inherent to the design allows enough movement for the cable carrier to track off of the support tray.This can lead to the reported event where the middle of the cable carrier falls off the support tray during normal system movement and remains suspended.Ct imager function was not impacted based on communications with the customer, and no scans were interrupted or repeated.Internal corrective action has been initiated to further address this issue.

• Brand Name: VISIUS SURGICAL THEATRE ICT
• Common Device Name: X-RAY SYSTEM, DIAGNOSTIC, COMPUTED TOMOGRAPHY, FULL-BODY
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer (Section G): 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: 15655505
• Report Number: 3010326005-2022-00015
• Device Sequence Number: 2455537
• Product Code: JAK
• UDI-Device Identifier: 00857534006219
• UDI-Public: 00857534006219
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K130224
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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: 115219-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2013
• 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