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

Model Number	480440-06
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2025
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 an in-house system.The instrument passed the recognition and engagement tests on 3 of 3 attempts.The instrument was recognized by the e-100 generator.Review of the master supervisory controller (msc) logs did not identify any recognition or engagement failures related to the instrument.Additional findings, non-related to the complaint, visual inspection revealed that the cut electrode was dislodged from its original position and was hanging outside the jaws.The cut electrode dislodged, and there may be missing pieces; however, the size of the missing pieces cannot be confirmed, indicating that a fragment may have detached from the instrument.Review of the instrument logs showed one "recoverable error: instrument cut electrodes shorted." on the e-100 generator.Energy logs showed three "cut electrodes shorted.".The probable root cause of the dislodged cut electrode was attributed to component susceptibility to damage.
Event or Problem Description
It was reported that during a da vinci-assisted liver resection surgical procedure, the synchroseal instrument did not register in the davinci arm.The synchroseal was removed and reinserted with poor effect.It was removed and a backup was opened which worked well.The procedure was completed with no report of patient harm.

• 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: 25263455
• Report Number: 2955842-2026-26202
• Device Sequence Number: 9205859
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(17)261130(10)K12241106
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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: K12241106 0275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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: ISIFA2022-01-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown