MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; VISION SYSTEM CART

Model Number	380941-44
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure that there was an ongoing issue with the monopolar energy cord connection at the energy shield monitor.The procedure continuously receive a ¿cord is damaged¿ message that interrupted energy delivery.The intuitive tech support engineer (tse) advised replacing the cord.The caller advised that this issue has occurred with multiple cords.The procedure was reportedly being completed as planned, with no reports of patient injury.How the issue was resolved was not specified.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Fse replaced the energy shield monitor (esm) to correct the reported event.The system was tested and verified as ready for use.Isi did receive a da vinci product involved with this complaint to perform failure analysis; however, the evaluation is not complete.The complaint was confirmed based on the field evaluation, which indicates that the device may have contributed to the customer reported issue.The missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The energy shield monitor (esm) was analyzed and found the neutral cable inserts were found damaged, replicating and confirming the reported event.The complaint regarding monopolar cord issues was confirmed by failure analysis.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The probable root cause is attributed to a faulty component which is the damaged neutral cable.
Event or Problem Description
Refer to h11 for follow-up information.

• 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 ; 4085232100
• MDR Report Key: 24684338
• Report Number: 2955842-2026-17645
• Device Sequence Number: 10042236
• Product Code: NAY
• UDI-Device Identifier: 00886874114742
• UDI-Public: (01)00886874114742
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• 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,Followup
• Report Date (Section B): 05/19/2026

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: 380941-44
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 03/27/2026; 04/24/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/20/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2021
• 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