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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The 8mm, synchroseal was analyzed and initial allegation could not be replicated or confirmed.Manual articulation was performed with no issue detected.Additional observations not reported by site were found, the instrument was found to have charring and localized melting on the outer surface of one cut electrode at the jaws.This damage resulted in the exposure of a section of the active electrode (jaws) that would not typically be exposed.A piece measuring approximately 1.70 mm × 0.70 mm was missing and was not returned with the device.Despite this, the instrument successfully passed the electrical continuity test.Additionally, the instrument was observed to have a torn jaw cover at the distal end.The jaw cover also appeared to be twisted inward, which could suggest melting; however, no evidence of thermal damage was found, and it was confirmed that no material was missing from the jaw cover.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.Probable root cause of thermal damage to jaws are attributed to insulation degradation and the presence of carbonized tissue, which can create unintended conductive pathways.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 8mm, synchroseal instrument was not recognized by the new dv5 system.The procedure was completed with no reported injury.Intuitive followed up and obtained additional information.The customer was not aware of any missing material on the complained product.No foreign body entered the patient.Since the synchroseal was not recognized by the dv5, it was not used on the patient.

• 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: 24848101
• Report Number: 2955842-2026-21238
• Device Sequence Number: 8946654
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(10)K11250814
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: 480440-06
• Device Catalogue Number: 480440
• Device Lot Number: K11250814 0184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• 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: 08/14/2025
• 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