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

Model Number	480440-07
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The synchroseal instrument has not been received for failure analysis evaluation.A review of an image provided by the customer was performed.Based on the image, the fragment could have potentially originated from damage to the main tube in the area.The jaw cover did not look damaged from the image.However, it cannot be confirmed if the fragment originated from the jaw cover.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, a fragment from the "coating" of a synchroseal instrument fell inside the patient's body.The fragment was not retrieved.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the synchroseal instrument was inspected before use and found to be normal.During surgery, interference between instruments on arm #3 and arm #4 caused a device fragment to fall inside the patient.The surgeon indicated that the instrument collision was the cause of the event and was committed to preventing such occurrences in the future.The instrument had been used for about 39 minutes without functional issues noted during the procedure.The fragment from the instrument was found postoperatively in infectious waste containing coagulated blood that was aspirated with a suction tube.No additional surgical procedures or postoperative tests were required, and the operation was completed robotically using the same instrument.There was no injury to the patient and no subsequent complications reported.

• 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: 25074905
• Report Number: 2955842-2026-23394
• Device Sequence Number: 10313800
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(10)K10250904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: K10250904 0298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown