MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci Energy; SynchroSeal

Model Number	480440-06
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Shock (2072)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a da vinci-assisted pancreatoduodenectomy procedure, the patient developed hemorrhagic shock secondary to postoperative bleeding, which required reoperation.The source and cause of the bleeding remain unclear.A synchroseal instrument was used during the procedure; however, the surgeon reported no intraoperative complications.The patient recovered and was discharged home.Additional information has been requested; however, no response has been received.
Additional Manufacturer Narrative
There was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.A review of the energy log shows that the synchroseal instrument (lot number: k13240829-0118) was installed 4 times on universal surgical manipulator (usm) #3.The system logs show 16 coag events with no errors, 96 seal events with 1 ¿high initial starting impedance¿ error, 125 transect events with 3 ¿high initial starting impedance¿ errors; which can typically occur when the user tries to seal/transect excessive tissue.The system logs show a "recoverable error: instrument high initial starting impedance" at the same time as one of the 3 errors seen for the transect events above.

• 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 ; +1(408)523-2100
• MDR Report Key: 50473373
• Report Number: 2955842-2026-37043
• Device Sequence Number: 10203808
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(17)260831(10)K13240829
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K191280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 480440-06
• Device Catalogue Number: 480440
• Device Lot Number: K13240829 0118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• 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