MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci Energy; SynchroSeal

Model Number	480440-06
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci assisted surgical procedure, a white plastic tip (fragment) broke from the synchroseal instrument and fell into the patient.A fragment fell into the patient and was retrieved during the same procedure.Post operative x-ray has been performed to confirm the complete retrieval of the fragment.The procedure was completed.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The synchroseal instrument was analyzed.Visual inspection found that the cut electrode was thermally damaged on the jaws.There was no material missing.This causes the jaws to pass energy inconsistently to the tissue.The synchroseal instrument was placed on in house system and passed engagement and recognition tests.The synchroseal instrument passed intuitive motion test.The jaws opened and closed properly.The synchroseal instrument could not be tested for sealing/cutting capabilities due to the instrument being returned with the cord cut.A review of the energy logs showed one "seal electrodes shorted".

• Brand Name: da Vinci Energy
• Common Device Name: SynchroSeal
• 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: 50201503
• Report Number: 2955842-2026-35161
• Device Sequence Number: 5545807
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(10)K13250220
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 480440-06
• Device Catalogue Number: 480440
• Device Lot Number: K13250220 0335
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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