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

Model Number	480440-07
Medical Device Problem Codes	No Device Output (1435); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a syncroseal had recognition issues.The procedure was completing as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The synchroseal instrument was analyzed and found to have a broken conductor in the housing near the back end pulleys.The instrument failed the electrical continuity test, confirming a complete break in the wire.No thermal damage was found on the instrument.Components adjacent to the broken wire do not show damage.As result of this break the instrument failed the energy delivery test during sealing with a warning message on the screen.The procedure logs showed errors "high initial starting impedance", most likely caused by the broken conductor wire.The complaint was confirmed by failure analysis.The root cause is attributed to a manufacturing failure during the conductor wire installation on the proximal end of the 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 ; +1(408)523-2100
• MDR Report Key: 50184440
• Report Number: 2955842-2026-35100
• Device Sequence Number: 13310414
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(10)K13251120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Notification
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: K13251120 0291
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2025
• 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: ISIFA2022-01-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: da Vinci Instruments and Accessories
• Patient Sex: Unknown