MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENERGY; SYNCHROSEAL

Model Number	480440-07
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.Video review: isi received a video clip related to the alleged complaint.A review of the video clip was conducted by the failure analysis engineer (fae).The following additional information was provided: the video shows the synchroseal instrument clamped on tissue and i could hear the energy delivery beep but no smoke appears to come out indicating a possible sealing/transect issue.No on-screen warnings or errors were seen so it¿s hard to assess what exactly is going on here.
Event or Problem Description
It was reported that during a da vinci-assisted wedge to completion lobectomy surgical procedure, the 8mm synchroseal failed to seal properly.The procedure was completed with no reported injury.Intuitive followed up and obtained additional information.Product was inspected prior to use and no abnormalities or unusual findings.The surgeon used the instrument for several minutes without any apparent issues; however, after that period, the instrument ceased to perform its intended function (it did not coagulate, seal, or cut ¿ ¿sync¿).The instrument functioned for approximately 7 minutes.No error displayed.Yes, a continuous tone was heard during the sealing attempt.No, the tone indicating successful completion of the sealing cycle or sync was not heard.Yes, the tissue was visually inspected to assess the effect.No, since the sealing cycle was not completed, the cut function was also not completed.The target tissue was a lymph node.It was not under excessive tension (only standard traction required for effective instrument use).The tissue between the jaws did not exceed 5 mm in diameter.There was no evidence of calcification, and the tissue had not been exposed to radiation or chemotherapy prior to the procedure.No, there were no metallic objects, sutures, or clips present when the event occurred.No bleeding occurred.The surgeon does not have a hypothesis regarding the cause of the issue, as the instrument had been functioning correctly only a few minutes earlier.The instrument was removed and was not used again (including no backup instrument).

• 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 ; 4085232100
• MDR Report Key: 25119066
• Report Number: 2955842-2026-24234
• Device Sequence Number: 10289508
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(17)270630(10)K11250617
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K191280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: K11250617 0093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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.
• Patient Sex: Unknown