MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS NEURO III-SV INTRA-OPERATIVE MRI SYSTEM; MAGNETIC RESONANCE IMAGING

Model Number 105117-004

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 01/02/2024

Event Type  Injury  

Event Description

It was reported that after using the mr magnet in an intra-operative procedure, during the steps to return the magnet to its home position, a nearby light boom attracted towards the magnet bore.A patient was on the operating room table and was reported to be struck by the light boom, causing a laceration.Further details on the event have been requested by the manufacturer with no further detail provided to date.

Manufacturer Narrative

A manufacturer service engineer investigated on-site on 2024-01-03 and 2024-01-04, which is when the manufacturer was made aware of the patient's involvement.Investigation on-site found there was no malfunction in the mri mover system.The magnet was reportedly in transit away from imaging position per user controls when the light boom attracted to the magnet bore.Attraction of ferromagnetic objects is an inherent property and risk in use of mri.Manufacturer contacted the manufacturer of the light boom involved for their awareness and assessment.Further details related to the sequence of events and patient impact have been requested by the manufacturer but not provided to date.The root cause is not determined at this time, a followup report is planned pending further information.

Manufacturer Narrative

Multiple attempts were made to gather additional information on the event reported and details surrounding patient impact.The customer responded that they would not disclose further information pending contact with their internal legal office.The clinical and health impact codes selected in the mdr reflect manufacturer's limited knowledge after attempting to gather further information on patient impact.An imris service engineer investigated the system while on-site and found no malfunction in the mri mover system.Prior preventive maintenance records were reviewed and support absence of any functional issues or anomalies that could potentially relate to the reported event.Based on available information the probable cause is inadvertent user error in positioning a ferromagnetic object too close to the mri magnet.

• Brand Name: IMRIS NEURO III-SV INTRA-OPERATIVE MRI SYSTEM
• Type of Device: MAGNETIC RESONANCE IMAGING
• 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: 18628484
• MDR Text Key: 334368630
• Report Number: 3010326005-2024-00002
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K083137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 105117-004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other