MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION NOBLUS

Model Number UN0581

Device Problems Computer Software Problem (1112); Application Program Problem (2880); Unintended Application Program Shut Down (4032)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

Fujifilm healthcare americas was notified of this complaint on 9/20/2021 regarding the noblus ultrasound system (un0581).The site reported that a patient was under anesthesia and undergoing a prostate cryo procedure with a bi-place c41l47rp probe.Site technician turned on the noblus system and attached the probe.The system would not boot up ready and reported an error asking to "please wait until the error log is complete." a prompt would pop up with the option to hit "ok", and when he did, the system would shut down.Tech attempted to reboot several times, both with and without a probe attached, and even tried to replace the battery.Error persisted.Fujifilm spoke with (b)(6) (reporting site technician) on 9/30/21 and confirmed that the patient was rescheduled for the procedure later in the week.There were no side effects from the anesthesia and the patient was cleared to go home.Error logs were sent to the manufacturer for review on 9/28/2021 and the system was returned to fujifilm for investigation.Investigation is ongoing at the time of this report.

Event Description

On september 20 2021, fujifilm healthcare americas received a report of an aborted procedure while patient was under anesthesia.The site was using the noblus ultrasound un0581.

Manufacturer Narrative

On december 01, 2021, fujifilm healthcare corporation concluded its root cause investigation.The device was observed to be damaged at multiple locations.Based on the type of damage, it was concluded that the device endured some kind of mechanical stress that likely occurred as a result of improper handling and/or storage of the device.

• Brand Name: NOBLUS
• Type of Device: NOBLUS
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer (Section G): FUJIFILM HEALTHCARE CORPORATION; 2-1 shinotoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: yasuo okamoto ; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0-804 ; JA 277-0804
• MDR Report Key: 12647907
• MDR Text Key: 276907783
• Report Number: 3018423337-2021-00001
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 04580292771704
• UDI-Public: (01)04580292771704(11)190419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UN0581
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2019
• 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
• Patient Sex: Male