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

Model Number	480440-07
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The synchroseal instrument was received for failure analysis.Visual inspection showed no signs of physical damage.No thermal damage was observed on the cutting electrode.Additionally, there was no missing ceramic dot, damaged jaw cover, cable damage, or missing material from the main tube insulation was identified.There was no missing material from the instrument.No missing material or metal shaving was observed in the jaw.No product issue was identified.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.
Event or Problem Description
It was reported that during a da vinci-assisted paraesophagial hiatal hernia procedure, the synchroseal instrument exhibited a metal shaving from its jaw.A fragment fell into the patient and was retrieved during the same procedure.At the surgeon¿s request, the instrument was replaced with a new synchroseal.The shaving fragment was immediately retrieved by the surgeon, after which the device was removed and replaced with a new one.No additional procedures were required, and there were no further complications.

• 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: 24872341
• Report Number: 2955842-2026-21384
• Device Sequence Number: 10028728
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(10)K10251106
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 480440-07
• Device Catalogue Number: 480440
• Device Lot Number: K10251106 0261
• 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: 03/17/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown