MAUDE Adverse Event Report: EIGEN ARTEMIS ULTRASOUND; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Device Problems Inadequate User Interface (2958); Operating System Becomes Nonfunctional (2996)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

The patient was positioned for an artemis ultrasound guided prostate biopsy, and had received sedation per anesthesia, and local anesthesia.The artemis mri/trus fusion machine malfunctioned.After 3 attempts at rebooting the system, the machine would not advance to the proper screens.Dr cancelled the procedure, and the patient was transported to pacu(post-anesthesia care unit).Will require a future procedure to complete biopsies.Fda safety report id# (b)(4).

• Brand Name: ARTEMIS ULTRASOUND
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): EIGEN; grass valley CA 95945
• MDR Report Key: 15893696
• MDR Text Key: 304697098
• Report Number: MW5113546
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White