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

Model Number ORT 400

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

The firm is investigating the observed phase shift or image distortion and factors such as eddy current compensation and protocol imaging parameters utilized, as well as potential eddy current interference from the operating room table.At this time a device malfunction has not been identified.A followup report will be submitted once the investigation has been completed.

Event Description

It was reported that during a magnetic resonance-guided litt procedure, the area intended for ablation appeared to be off target, prior to ablation.The case was completed and no patient or procedural impact or consequence was reported.The planned therapy was delivered after the neurosurgeon compensated for the observed shift in imaging.

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
• Type of Device: 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: 12801533
• MDR Text Key: 285343725
• Report Number: 3010326005-2021-00015
• Device Sequence Number: 1
• Product Code: KXJ
• UDI-Device Identifier: 00857534006691
• UDI-Public: (01)00857534006691(11)200310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

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
• Device Model Number: ORT 400
• Device Catalogue Number: 119493-000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1