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

Model Number	480440-06
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure, the synchroseal instrument turns off/flashes yellow on the tower randomly when trying to fire.The procedure was completed with no patient harm.
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 placed and driven on an in-house system.The instrument passed the recognition and engagement tests on 3 of 3 attempts.The instrument passed seal test on 3 of 3 attempts.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.There was no failure reported in the logs review.Additional unrelated findings that not reported by site: visual inspection found the cut electrode thermally damaged on the jaw.There was no material missing.The instrument was placed on in house system and passed engagement and recognition tests.The seal test was performed and passed.Further, the instrument was found to have the jaw cover torn.The tears measured roughly 0.114" x 0.092".Visual inspection displayed no signs of missing fragments.There were no signs of thermal damage present at the end of any tears.The probable root cause of the thermally damaged cut electrode on the jaw was attributed to component failure.The probable root cause of the torn jaw cover was attributed to the user.

• 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: 25024491
• Report Number: 2955842-2026-23200
• Device Sequence Number: 9039668
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(17)270831(10)K11250807
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/28/2026

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: K11250807 0248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/29/2026
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White