MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci; HARMONIC ACE

Model Number	480275-12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted procedure, a screw on a harmonic ace instrument was observed to have loosened or broken and a fragment fell inside the patient.The fragment was retrieved during the same surgery.The customer stated that the broken fragment was immediately retrieved using a long forceps instrument along with another robotic arm.To confirm complete retrieval, the surgical site was thoroughly irrigated and carefully inspected using the da vinci robotic endoscope, ensuring no fragments remained in the area.A postoperative ultrasound examination was conducted following the visual confirmation that no residual fragment was present.
Additional Manufacturer Narrative
The harmonic ace instrument has not been received for failure analysis evaluation.

• Brand Name: da Vinci
• Common Device Name: HARMONIC ACE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; +1(408)523-2100
• MDR Report Key: 50899446
• Report Number: 2955842-2026-39854
• Device Sequence Number: 10711812
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)281130(10)K11251113
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K143132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 480275-12
• Device Catalogue Number: 480275
• Device Lot Number: K11251113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: da Vinci Instruments and Accessories.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown