MAUDE Adverse Event Report: FUJIFILM CORPORATION PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	PROSOUND F75
Medical Device Problem Codes	Image Display Error/Artifact (1304); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On may 23rd 2024, fujifilm healthcare americas corporation was informed of an event involving prosound f75.It was reported that the ultrasound image flipped by itself during biopsy.Physician canceled the patient biopsy and customer are upset and they don't trust their ultrasound unit.Dr.Complained that they are waiting 2 weeks before getting their equipment repair.The procedure was not completed.Physican canceled and postponed the patient diagnosis for pancreas cancer.Initially, based on the available information, the manufacturer, fujifilm corporation, determined that manufacturer mdr is not necessary.However, after new information became available from the site (07/02/2024), fujifilm corporation is further investigating the event.This manufacturer's mdr is being submitted in abundance of caution.
Additional Manufacturer Narrative
Ref (b)(4).
Event or Problem Description
Clarification of relevant timeline added.On may 23rd 2024, fujifilm healthcare americas corporation was informed of an event involving prosound f75.It was reported that the ultrasound image flipped by itself during biopsy.Physician canceled the patient biopsy and customer are upset and they don't trust their ultrasound unit.Dr.Complained that they are waiting 2 weeks before getting their equipment repair.The procedure was not completed.Physican canceled and postponed the patient diagnosis for pancreas cancer.Based on the information available on june 12th, 2024, the manufacturer, fujifilm corporation, determined that manufacturer mdr is not necessary.However, after new information became available from the site (july 2nd, 2024), fujifilm corporation started investigating the event.This manufacturer mdr was submitted in abundance of caution on july, 2024.
Additional Manufacturer Narrative
B5 updated to include june 12th, 2024, as date of initial reportability assessment.
Additional Manufacturer Narrative
B5 updated to include the conclusion of the investigation from olympus.
Event or Problem Description
On may 23rd 2024, fujifilm healthcare americas corporation was informed of an event involving prosound f75.It was reported that the ultrasound image flipped by itself during biopsy.Physician canceled the patient biopsy and customer are upset and they don't trust their ultrasound unit.Dr.Complained that they are waiting 2 weeks before getting their equipment repair.The procedure was not completed.Physician canceled and postponed the patient diagnosis for pancreas cancer.Based on the information available on (b)(6), 2024, the manufacturer, fujifilm corporation, determined that manufacturer mdr is not necessary.However, after new information became available from the site ((b)(6) 2024), fujifilm corporation started investigating the event.Fujifilm corporation reached out to olympus contact for details on the investigation.Per the olympus contact, the investigation determined that the issue was the olympus scope and not the ultrasound processor.

• Brand Name: PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer Contact: 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538
• MDR Report Key: 19840477
• Report Number: 3018423337-2024-00007
• Device Sequence Number: 6768806
• Product Code: IYN
• UDI-Device Identifier: 04562122956185
• UDI-Public: 04562122956185
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PROSOUND F75
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/05/2024; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown