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

Model Number	380941-45
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse replaced the energy shield monitor (esm) to resolve the issue.The system was tested and verified as ready for use.Isi did receive the esm product involved with this complaint to perform failure analysis.The esm was found with errors indicating node not present, confirming the fault occurred in the field.Upon visual inspection, the left controller area network (can) electrosurgical unit (esu) screw insert was found damaged.The unit was installed onto a golden system and functioned as expected.The unit was left to idle for approximately 2 hours; however, no faults or errors occurred.All leds were observed on and functioned as expected.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted left nephroureterectomy surgical procedure, the customer contacted a intuitive surgical inc.(isi) technical support engineer (tse) and reported that the energy shield monitor (esm) would not light up and a message on the monitor indicated that the energy shield could not be detected.The tse instructed the customer to check all the cables on the back of the esm to ensure they were fully seated, which they were.The customer also checked the cables on the other end, which were also fully seated.The customer mentioned a screen message indicating that the video processor (vp) was not detected.Upon checking, the gray fiber was found to be missing, so the customer used a fiber from another system to connect the vp to the core.The tse also had the customer check the rocker switch to ensure it was in the on position.A hard power cycle of the system was performed, but the esm still did not light up.The erbe was on, with monopolar and neutral pad connections plugged in.The customer noted that another system had issues with arm 1 and that two cases were scheduled for next week.The customer requested that the field service engineer (fse) repair the systems before the scheduled cases.No live logs were available during the call.Isi followed up with the nurse and obtained the following additional information: the issue occurred pre-anesthesia, before the patient was brought into the operating room (or) and no ports were placed.The procedure was a robotic assisted left nephroureterectomy that was converted to traditional laparoscopic surgery which required the placement of additional ports.The patient tolerated the change.

• 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: 24716660
• Report Number: 2955842-2026-19186
• Device Sequence Number: 12203229
• Product Code: NAY
• UDI-Device Identifier: 00886874114742
• UDI-Public: (01)00886874114742
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 380941-45
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian