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

Model Number	480440-07
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The synchroseal has been returned and evaluated by the failure analysis (fa) team.The instrument was found to have a broken snake wrist cable at the distal end.The broken cable did not affect functionality or intuitive motion.Failure analysis found the failure of cut electrode.Thermal damage to be related to the customer reported complaint.Visual inspection found the cut electrode to have an indented surface of the electrode.There was no material missing.This causes the jaws to pass energy inconsistently to the tissue.The instrument was placed on in house system and passed engagement and recognition tests.The seal test was performed and passed 3 out 3 attempts.Review of the msc logs showed one "e-100 error: recoverable error: instrument cut electrodes shorted".Energy logs showed one "cut electrodes shorted." root cause is attributed to component failure.The instrument was found to have the jaw cover torn.The tears measured roughly 0.1725" x 0.1260".The jaw cover torn and there may be missing pieces, but the size of the missing pieces cannot be confirmed.There are no signs of thermal damage present at the end of any tears of the jaw cover.Root cause is attributed to component susceptibility to damage.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 8mm synchroseal had a frayed cable.The procedure was completing as planned with no reported injury.

• 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: 24848728
• Report Number: 2955842-2026-21234
• Device Sequence Number: 5790294
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(10)K10250807
• 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
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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: K10250807 0390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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