MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci SP; VISION SYSTEM CART

Model Number	380941-55
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a remote site representative had contacted the intuitive surgical, inc.(isi) technical support engineer (tse) on behalf of the user site to report that monopolar energy could not be activated and that the cord indicator on the energy switch module had been amber while the other indicators had been blue.Prior to the call, users had verified that all cords had been connected correctly and had replaced the energy cord and the instrument, but the issue had persisted.The tse had asked the caller to verify that the instrument cord had been connected to the energy switch module rather than the generator, and the caller had confirmed this had already been verified based on a photo of the setup.The tse had then advised restarting the system, and the caller had planned to relay that instruction to the user site and call back; the call had ended before additional troubleshooting details had been obtained.The procedure outcome is unknown with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the case was completed robotically but the monopolar energy wasn't work at all.The customer tried the cable changing, emergency power off (epo), everything but nothing was changed.The surgeon cut the tissues without using energy.There was a such a big delay of course maybe more than 60min.The total operation time was almost 5hours.At the end of the surgery, the monopolar energy suddenly worked.After the surgery their technical support came to fix the system but the energy was working correctly; so they could not do anything.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The reported event was addressed with phone support.The technical support engineer (tse) advised the customer to restart the system.No site visit was conducted.The system was working properly, and no additional action was required as the issue was resolved.

• Brand Name: da Vinci SP
• Common Device Name: VISION SYSTEM CART
• 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: 50928033
• Report Number: 2955842-2026-40296
• Device Sequence Number: 13443070
• Product Code: NAY
• UDI-Device Identifier: 00886874114742
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• 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: 380941-55
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2026
• Is the Device Labeled for Single Use? (Y/N): No
• 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