MAUDE Adverse Event Report: FUJIFILM CORPORATION ARIETTA PRECISION; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	L44LA
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product was installed in (b)(6) 2019, and since the product's service life is 3 years, it has already exceeded 2.5 years.After investigating the product where the incident occurred, we determined that the filling material had fallen off due to aging of the product.
Event or Problem Description
On june 16, 2025, fujifilm corporation received a customer complaint.During laparoscopic surgery at a medical facility in japan, part of the filler material from the l44la probe detached and entered the patient's body.The physician noticed the detached filler material at the scene and removed it.There were no adverse health effects from the filler, but the procedure took longer than expected because some of the filler had to be removed.

• Brand Name: ARIETTA PRECISION
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): FUJIFILM CORPORATION; 3-1-1 higashikoigakubo; kokubunji-shi; tokyo, 185-0 014; JA 185-0014
• Manufacturer (Section G): FUJIFILM HEALTHCARE MANUFACTURING CORPORATION; 2-1, shintoyofuta; kashiwa-shi; chiba, 277-0 804; JA 277-0804
• Manufacturer Contact: 3-1-1 higashikoigakubo; kokubunji-shi; tokyo, 185-0-014
• MDR Report Key: 22504701
• Report Number: 3019784575-2025-00002
• Device Sequence Number: 12924655
• Product Code: ITX
• UDI-Device Identifier: 04562122958431
• UDI-Public: (01)04562122958431(11)20191101
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: L44LA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2019
• 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: Required Intervention
• Patient Sex: Unknown