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

Model Number ORT200

Device Problem Unintended Movement (3026)

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

Event Date 10/26/2022

Event Type  malfunction  

Event Description

It was reported that during a laser ablation (litt) procedure, approximately 9mm of anterior to posterior drift was detected within an approximately 3 hour time interval, when using the ort200 operating room table.The customer reported additional scans were taken at the surgeon's discretion throughout the case to ensure accurate thermal mapping.The customer reported the case was completed successfully and no patient injury was reported.

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.A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

The manufacturer investigated and addressed the reported event on-site after gaining access to the operating room table.The trend cylinder and two dual counterbalance valves were replaced within the table's hydraulic system, and confirmed to correct the reported drift in trendeleburg position through subsequent testing of the operating room table.The probable cause for the drift event is hydraulic fluid leakage through the seals of the counterbalance valves in the hydraulic manifold and potential downstream leakage through the seals in the trend cylinder.The hydraulic fluid in the table was also flushed during the replacement of the table components.Patient demographics information was requested but not provided by the customer.Internal corrective action has been initiated by the manufacturer to further address this issue.

• Brand Name: IMRIS ORT200 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 (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: 15879995
• MDR Text Key: 307708764
• Report Number: 3010326005-2022-00016
• Device Sequence Number: 1
• Product Code: KXJ
• 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: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORT200
• Device Catalogue Number: 113821-600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2011
• 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