MAUDE Adverse Event Report: FUJIFILM CORPORATION L51K; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	L51K
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the surgical procedure with a da vinci robot, in which the ultrasound probe is inserted into the body through a trocar and hold by a grasping forceps, parts of the cable sheath broke off.There was no clinical impact on the patient.The detached fragments of the cable sheath were immediately visualized on the camera during the procedure and removed without difficulty.
Additional Manufacturer Narrative
We conform the following things: the cable shows significant signs of use and wear, marks from foreceps were identified.
Additional Manufacturer Narrative
The investigation concluded that the manufacturer's genuine parts were not the cause of this incident.The cable showed clear signs of wear.Marks caused by forceps were also observed.Therefore, we determined that the cable had been handled improperly, contrary to the instructions in the instruction manual.Visible cracks indicated damage that had occurred over a long period of time.The damage did not occur during use and should have been detected by the user during a pre-use inspection.The instruction manual includes instructions regarding pre-use inspections.

• Brand Name: L51K
• 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 CORPORATION; 3-1-1 higashikoigakubo; kokubunji-shi, tokyo 185-0 014,; JA 185-0014,
• Manufacturer Contact: 3-1-1 higashikoigakubo; kokubunji-shi, tokyo 185-0-014,
• MDR Report Key: 24709785
• Report Number: 3019784575-2026-00001
• Device Sequence Number: 12292503
• Product Code: ITX
• UDI-Device Identifier: 04573596212134
• UDI-Public: (01)04573596212134(11)220804
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: L51K
• 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: 02/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown