MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION NOBLUS

Model Number	UN0581
Medical Device Problem Codes	Computer Software Problem (1112); Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3018423337-2021-00001
• Device Sequence Number: 1309715
• Product Code: IYN
• UDI-Device Identifier: 04580292771704
• UDI-Public: (01)04580292771704(11)190419
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K160559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UN0581
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male