MAUDE Adverse Event Report: FUJIFILM HEALTHCARE AMERICAS CORPORATION UST-9150; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number N/A

Device Problems Break (1069); Mechanical Jam (2983)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

On june 27, 2023, fujifilm healthcare americas corporation became aware of an event involving ust-9150.It was reported that the ultrasonic probe broke during a procedure, and the up/down mechanical function did not work.The procedure was completed successfully using another device.There is no death or serious injury associated with the event.As such, this report is being submitted in abundance of caution.

Manufacturer Narrative

A supplemental report will be submitted pending investigation results.

Manufacturer Narrative

Verification of durability, including unexpected conditions, and risk mitigation of use have been conducted properly, and no design control deficiencies were found.As described in the clinical use requirements and the instruction manual, the laparoscopic probe is a delicate instrument and the probe tip is difficult to see during the imaging process, making it difficult to eliminate the possibility of unintentional excessive force being applied to the probe tip.It is difficult to determine a cause-and-effect relationship this time because it is not known through what kind of probe operation the failure occurred.It may be due to overloading, misuse, or a combination of these factors.Since the damage was not critical, such as the probe tip being fixed with a bent tip and not being able to be removed from a trocar, and since it occurred infrequently, it is considered appropriate to address the problem through repair.

• Brand Name: UST-9150
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): FUJIFILM HEALTHCARE AMERICAS CORPORATION; 1959 summit commerce park; twinsburg OH 44087
• Manufacturer (Section G): FUJIFILM HEALTHCARE AMERICAS CORPORATION; 1959 summit commerce park; twinsburg 44087
• Manufacturer Contact: randy vader ; 1959 summit commerce park; twinsburg, OH 44087 ; 3603566821
• MDR Report Key: 17396407
• MDR Text Key: 319788901
• Report Number: 1528028-2023-00007
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

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
• Device Operator: 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?: No
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1