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

Model Number	480440-06
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The synchroseal instrument was analyzed, and the findings did not replicate or confirm the customer reported event.The instrument was tested on our in-house system and passed initialization.The instrument passed the recognition and engagement tests multiple times.The instrument moved intuitively with full range of motion in all directions.The jaws opened and closed properly.The instrument was contacted to the erbe generator and passed energy recognition.The instrument was connected to an in-house bipolar cautery cable on in-house system and passed energy delivery test.The instrument cut test was also passed.The instrument was fully functional.Additional unrelated observation: the instrument was found to have a torn jaw cover at the distal end.Additionally, the jaw cover appeared to be twisted inward, giving the appearance of being melted; however, no evidence of thermal damage was observed.It was also confirmed that there was no material missing from the jaw cover.Common causes of the failure mode torn jaw cover are typically attributed to the user, such as excessive contact with abrasive or hard surfaces during use or reprocessing.The missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
Event or Problem Description
It was reported that during a da vinci-assisted malignant hysterectomy surgical procedure, the synchroseal did not respond to commands.The procedure was completed with no report of patient harm, adverse outcome or injury.There were no delays.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 27-nov-2025: the complete batch number of the synchroseal is 480440-06/k15241127 0359.The instrument was inspected prior to use and nothing out of the ordinary was noticed.The issue occurred while trying to reach the vessel.The issue occurred with the surgeon¿s head inside the surgeon console¿s high resolution stereo viewer, while surgeon was attempting to manipulate instruments from the surgeon side console (ssc).The issue was related to an inability to move the instrument at all.There was no instrument-to-instrument or system arm-to-arm interference.

• 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: 24934404
• Report Number: 2955842-2026-22273
• Device Sequence Number: 10652349
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(10)K15241127
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K191280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: 480440-06
• Device Catalogue Number: 480440
• Device Lot Number: K15241127 0359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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: Female