MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENERGY; VESSEL SEALER CURVED

Model Number	480522-02
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the vessel sealer curved instrument associated with this complaint.The instrument was tested on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with a full range of motion in all directions.The grip tips opened and closed properly.The instrument passed the cut test with no issues.The instrument passed energy-delivery testing across various grip orientations.The instrument also passed the electrical continuity test.The instrument was fully functional.The logs show no vessel sealer curved related errors.The first vessel sealer curved instrument (lot # u10250929-0152) instrument was used for 69 minutes and the second vessel sealer curved instrument was used for about 17 minutes.The activation event logs show a total of 417 events between the two instruments, with no errors.
Event or Problem Description
It was reported that during a da vinci-assisted transverse colectomy procedure, the vessel sealer curved instrument produced an incomplete seal cycle on the inferior mesenteric artery (ima) and the instrument became stuck to tissue.Another instrument was used to pry the stuck tissue from the vessel sealer curved instrument.The attempted sealed tissue of the ima was inspected and found that the tissue did not seal.The tissue was not cut.The surgeon opted to staple both side of the vessel to reinforce the seal.No bleeding occurred due to the insufficient seal.The procedure was completed robotically.
Additional Manufacturer Narrative
Device evaluation: initial findings were confirmed.No functional issues were found with the instrument.Logs were reviewed to check for any sealing issues/malfunctions to verify the customer complaint.The instrument was used for about 69 minutes, and qty 417 seagull_seal events were noted, with no errors.No sealing issues were identified from the logs.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DA VINCI ENERGY
• Common Device Name: VESSEL SEALER CURVED
• 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: 24600315
• Report Number: 2955842-2026-15973
• Device Sequence Number: 8365940
• Product Code: NAY
• UDI-Device Identifier: 10886874123369
• UDI-Public: (01)10886874123369(10)U10250929
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K250674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 480522-02
• Device Catalogue Number: 480522
• Device Lot Number: U10250929 0152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/14/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2025
• 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 Age: 72 YR
• Patient Sex: Male