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

Model Number	480522-02
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the vessel sealer curved instrument to perform failure analysis.The instrument exhibited imprecise motion.The instrument was installed on an in-house system and passed the self-test.The grip tips moved within the joint limits; however, they failed to open.The instrument was found to have a bent main tube at around the proximal end of the instrument.The instrument was found to have one of the idler pulleys dislodged.The idler pulley was found inside of the housing.In addition, the vessel sealer curved instrument was found to have one of the dowel pins dislodged and inside of the housing.
Event or Problem Description
It was reported that during a da vinci-assisted sleeve to duodenal switch revision surgical procedure, the vessel sealer curved instrument jaws stopped working.The customer completed the procedure with no further issue reported.No known impact or patient consequence was reported.Intuitive followed up and obtained additional information.Jaws were not stuck on tissue during the issue.No unexpected tissue removal occurred.There was no bleeding.The vessel sealer curved instrument worked for half of the case.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) perform advance failure analysis (afa) for the vessel sealer extend instrument.The initial findings were confirmed.Afa analysis found a loose grip cable at the proximal end, on the lower side where it is wound around the grip input.As a result, the grips would not open when the instrument was manipulated on the surgeon side console but would open when the grip open lever was pressed.A loss of tension in the grip cable can cause the dowel pin and pulley to get dislodged.A review of the instrument logs shows that the instrument was used for about 25 minutes.It was noted there were no strong grip fail errors.The probable root cause of the loose grip cable is attributed to component susceptibility to damage through external collisions or during use.A loose grip cable can prevent the grips from fully closing, leading to the instrument failing self-test/homing (initialization) or causing low torque errors.The dislodged pulley and dowel pin were a direct result of the loose grip cable.Furthermore, the probable root cause of the bent main tube is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments.Applying excessive force on the instrument shafts and/or tips during handling, insertion, usage (overloading), or removal can also cause bending.

• 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: 24062152
• Report Number: 2955842-2026-00750
• Device Sequence Number: 10385578
• Product Code: NAY
• UDI-Device Identifier: 10886874123369
• UDI-Public: (01)10886874123369(10)U10250902
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 480522-02
• Device Catalogue Number: 480522
• Device Lot Number: U10250902 0110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• 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
• Patient Sex: Unknown