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

Model Number	480440-07
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: during a follow-up case on 03-sep-2026, clinical sales manager observed that the surgeon was applying the coag function before using synchroseal instrument synch mode on thin fibro-fatty tissue.When coag was used first, the system frequently displayed an ¿incomplete seal cycle¿ message.After being advised that synch mode already performs both sealing and cutting and does not require prior coag application, the surgeon used synch alone and the frequency of incomplete seal cycle messages decreased significantly.The reported issue was that the synchroseal instrument was not achieving a seal despite energy appearing to be present.No delayed sealing, partial sealing, arcing, bleeding, tissue cutting, metal contact, liquid contamination, or bio-debris contamination were reported.The instrument did not successfully seal during the procedure, and an ¿incomplete seal cycle¿ error was observed with audible tones indicating that the seal cycle had not completed.The tissue was reported to be very thin and under tension, and photos from the follow-up case were provided for review.Isi did receive a da vinci product to perform failure analysis.The synchroseal instrument was analyzed, and the complaint was not confirmed by failure analysis.Visual inspection displayed no signs of physical damage.No thermal damage to the cut electrode and no excessive bio debris.Review of the master supervisory controller (msc) showed one e100 recoverable error; however, it was not a failure.A high impedance error was triggered when the user attempted to seal or transect too much tissue between the jaws.Review of the energy logs showed no errors.The energy logs showed 27 high initial starting impedance, which is not considered a failure, as it means a high impedance error is triggered when the user attempts to seal or transect too much tissue between the jaws.No cut electrode shorted errors were shown on the energy logs.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests and passed the energy recognition on 3 out of 3 attempts.The instrument sealed and transected successfully in 3 of 3 attempts.The instrument moved intuitively with full range of motion in all directions.No product issue was identified.

• 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: 50593223
• Report Number: 2955842-2026-37550
• Device Sequence Number: 18499960
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(17)280131(10)K11260122
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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
• Operator of Device: Health Professional
• Device Model Number: 480440-07
• Device Catalogue Number: 480440
• Device Lot Number: K11260122 0057
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2026
• 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
• Patient Sex: Unknown