MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci Xi; VISION SIDE SYSTEM, RECONDITIONED

Model Number	380721-10
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted transvesical prostatectomy procedure, an error on the erbe generator occurred during coagulation.Prior to calling an intuitive surgical, inc.(isi) technical support engineer (tse), the customer rebooted the erbe generator, disconnected and reconnected the energy cables.The tse inquired about the monopolar energy settings.The customer stated the monopolar energy was at level 3 with swift mode.The tse asked what error codes were observed as the system was offline.The customer identified a possible error.The tse asked the customer to switch to classic mode, but the error persisted.The tse advised the customer to shut down and unplug the erbe generator, and wait 10 to 15 seconds before restarting the unit.After rebooting, two possibly related errors were observed.The tse advised the customer to use a backup generator or another da vinci system; however, the customer said there was no available backup.The customer elected to abort the procedure after ports had already been placed.The procedure was rescheduled and completed the next day.The patient is reported to be doing well.
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 erbe generator was replaced to correct the reported problem.The system was tested and verified as ready for use.Isi did not receive a da vinci product involved with this complaint to perform failure analysis.

• Brand Name: da Vinci Xi
• Common Device Name: VISION SIDE SYSTEM, RECONDITIONED
• 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: 50228451
• Report Number: 2955842-2026-34404
• Device Sequence Number: 10297029
• Product Code: NAY
• UDI-Device Identifier: 00886874115343
• UDI-Public: (01)00886874115343
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131861
• 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): 08/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 380721-10
• Device Catalogue Number: 380721
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2021
• 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: Reuse
• 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 Sex: Unknown