MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION NOBLUS

Model Number	N/A
Medical Device Problem Code	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
Event or Problem Description
On (b)(6) 2021, fujifilm healthcare americas corporation (formerly hitachi healthcare americas corporation) received a complaint regarding noblus ultrasound.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.The procedure was rescheduled.There were no side effects from the anesthesia and the patient was cleared to go home.There was no injury/harm or death reported with this event.During a retrospective review, it was discovered that the manufacturer had assessed this event as ae leading to serious injury; therefore an importer's mdr is being submitted.

• Brand Name: NOBLUS
• Common Device Name: NOBLUS
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi; chiba-ken 277-0 704; JA 277-0704
• MDR Report Key: 13686566
• Report Number: 1528028-2022-00014
• Device Sequence Number: 1944430
• 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
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2022

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: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/20/2021
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male