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	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the vessel sealer curved instrument jaws would not open.The procedure was completed.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there was no injury to the patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the vessel sealer curved (vsc) instrument to perform failure analysis (fa).Fa was able to confirm the reported complaint.The instrument was found to have the grip ring dislodged at the proximal end (in the housing).As a result, the instrument grips would not open when driven on the system or when the grip open lever was used.The grip ring set screw was found rattling inside of the housing.Additionally, the vsc instrument exhibited imprecise motion during grip open function.The grip tips moved within the joint limits and in the commanded direction; however, the grips would not open.The instrument was found to have the grip ring dislodged which prevented the grips from opening as expected.The probable root cause is attributed to the observed dislodged instrument grip ring not up against lever during the set grip ring position process step.

• 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: 50927498
• Report Number: 2955842-2026-40134
• Device Sequence Number: 9734249
• Product Code: NAY
• UDI-Device Identifier: 10886874123369
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 09/28/2026

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: K14260701 0192
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2026
• 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
• Patient Sex: Unknown