MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci Energy; Vessel Sealer Curved

Model Number	480522-02
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a da vinci-assisted benign hysterectomy surgical procedure, the patient sustained a right ureter leak 5-7 days post operatively.Although the occurrence of an injury was not visualized during the initial procedure, the surgeon believes the elbow of the vessel sealer curved (vsc) instrument had a delayed thermal injury to the right ureter due to thermal spread.After the initial procedure, cystoscopy was performed to assess the ureteral jets and they were fine.The surgeon reports that the patient's anatomy was very challenging, the uterus contained fibroids that were extremely large like a volleyball.Due to the large uterus, the surgeon did not have a lot of clearance between the ureter and the bowel so the elbow of the vsc was pressed up against and hitting the patient's sidewall frequently while sealing vessels.As a result of the leak, the patient required a nephrostomy tube and pelvic drain.The surgeon plans for ureteral reimplantation after about 6 to 7 weeks.
Additional Manufacturer Narrative
The vessel sealer curved instrument used during this event was not received for failure analysis investigations.The vessel sealer curved instrument lot number u11260409-0204 was installed 2 times on universal surgical manipulator (usm) 2.E-200 generator logs show a total of 1 bipolar event and 120 seal events with no relevant errors.The instrument was used for about 29 minutes.

• 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 ; +1(408)523-2100
• MDR Report Key: 50141528
• Report Number: 2955842-2026-34322
• Device Sequence Number: 13448267
• Product Code: NAY
• UDI-Device Identifier: 10886874123369
• UDI-Public: (01)10886874123369(10)U11260409
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 08/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 480522-02
• Device Catalogue Number: 480522
• Device Lot Number: U11260409 0204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2026
• 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