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	07/08/2026
Type of Reportable Event	Other
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the vessel sealer curved instrument was hot and blanched the urachus while sealing the round ligament.The surgeon did not perform any interventions and reported it as minor non-consequential thermal spread.The procedure was completed as planned.After the procedure, cystoscopy was performed to assess ureteral jets and they were fine.
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: k11260528-0198 was installed 1 time on universal surgical manipulator (usm) 2.E-200 generator logs showed a total of 168 seal events with 2 high z errors, indicating a high impedance situation either due to excessive bio-debris between the jaws or excessive tissue during sealing.The instrument was used for about 26 minutes.The system logs don¿t show any instrument related errors.

• 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: 50141443
• Report Number: 2955842-2026-34321
• Device Sequence Number: 9350011
• Product Code: NAY
• UDI-Device Identifier: 10886874123369
• UDI-Public: (01)10886874123369(10)K11260528
• 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: K11260528 0198
• 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: 05/28/2026
• 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: Other
• Patient Sex: Unknown