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

Model Number	480522-02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the curved vessel sealer instrument to perform failure analysis.Failure analysis investigations confirmed the customer reported complaint.The instrument was analyzed and found to have a dislodged conductor wire dislodged at the distal end.The conductor wire was pulled out of the clevis at the distal end.The instrument passed an electrical continuity test.Further evaluation found one of the yaw / pitch inputs of the instrument was dislodged.The instrument input disk retaining ring and bearing were dislodged which caused the input to also become dislodged.The retaining ring and the bearing were found inside of the housing.Advance failure analys (afa) was performed, and the initial findings were confirmed.It was noted that the bearings from both the pitch and yaw inputs were dislodged, which can result from a missing or dislodged retaining ring.Dislodged retaining ring and dislodged bearing can eventually cause a dislodged input disk.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the surgeon was using a monopolar curved scissors (mcs) instrument to manipulate the tissue.While doing so, the surgeon accidently hooked the cautery wire of the curved vessel sealer instrument with the jaws of mcs instrument and pulled it out of place.The curved vessel sealer instrument was not in contact with tissue at the time, and the surgeon noticed a snagged cautery wire.The procedure was paused and the curved vessel sealer instrument was replaced.The procedure was completed with no reported injury.

• 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: 24007052
• Report Number: 2955842-2026-00542
• Device Sequence Number: 9215290
• Product Code: NAY
• UDI-Device Identifier: 10886874123369
• UDI-Public: (01)10886874123369(10)U10250603
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/08/2026

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: U10250603 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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