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

Model Number	480440-07
Medical Device Problem Codes	Failure to Deliver Energy (1211); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the synchroseal would not work.The user converted the procedure to laparoscopic surgery with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the team tried open more new supplies did not work and surgeon wish converted to traditional laparoscopic surgery and used ligasure to complete the case on time.The patient tolerated the conversion with no injury reported.The instrument did not work at all.There was no audible sound when pressed and no tones.There was no sealing and no cutting.There was no bleeding observed.There were no error messages and technical support found no error messages in the logs.There are no video recordings for isi to review.
Additional Manufacturer Narrative
The vessel sealer extend has been returned and evaluated by the failure analysis (fa) team.The instrument was found to have a broken white seal conductor wire at the conductor wire at the crimp inside of the housing.The instrument failed the electrical continuity test.The wire was fully broken, and the conductor wires were exposed.No signs of thermal damage were observed.Components adjacent to the broken wire do not show damage.The instrument was placed on an in-house system.The instrument passed the recognition and engagement test but failed the energy delivery and seal test.The synchroseal did not work as a result of broken conductor wire at the crimp.Additional findings related to customer reported complaint: the instrument failed the electrical continuity test during an inspection.The instrument was placed on an in-house system.The instrument passed the recognition and engagement test but failed the energy delivery and seal test.Additional observation(s) not reported by site: the instrument was found to have a bent main tube.The bending damage is located at the midpoint area.Components adjacent to this bent main tube do not show damage.The probable root cause is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments.Applying excessive force on the instrument shafts and/or tips during handling, insertion, usage (overloading), or removal can also cause bending.

• 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: 25151187
• Report Number: 2955842-2026-24801
• Device Sequence Number: 10750228
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(10)K10250709
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K191280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: K10250709 0198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White