MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC daVinci 5; Vision Side Cart

Model Number	380746-46
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted abdonimoperineal resection procedure, the operating room staff called intuitive surgical inc.(isi) technical support engineers (tse) to state the left eye image was split on both surgeon side console (ssc) 1 and 2.The customer replaced the endoscope, but the issue remained.At the time of the call the customer was unable to power cycle the system due to active bleeding from the renal artery.It was reported that the bleeding from the renal artery started prior to the reported event; however, the split image on the left eye did cause it to take longer to suture the artery and stop the bleeding.The estimated blood loss was not provided; however, it was reported the patient received 3 units of blood and was admitted intubated to the intensive care unit (icu) post-operatively.After the bleeding was controlled a second call was made to isi tse and it was stated the staff was able to perform a hard power cycle to the system; however, the endoscope would not initiate.A second hard power cycle was performed, and an image was produced for a few moments before it was lost.Tse reviewed live system logs and saw an error from tower fiber port 1 going to ssc 2.Tse asked that the caller remove the blue fiber cable from ssc 2 and saw that ssc 1 was disconnected.The caller stated that the consoles are "daisy chained" and ssc 2 was not connected.The staff powered on the system and experienced the same error for console not connected to system.Tse asked the caller to move the blue fiber cable from the current console to the other one, but caller was unable to do so.The decision was made to convert the procedure to another da vinci 5 system.There was a delay of greater than 30 minutes.The surgeon stated the system did not cause the bleeding event "but had a failure that delayed control of bleeding and lengthened the case time as we rebooted the system several times and ultimately brought over a second tower and console from another or." the surgeon stated the patient is morbidly obese, otherwise they may have made the decision to convert to an open procedure.However, it was reported that once the bleeding was under control, it was worth the prolonged delay to troubleshoot the system.The patient's weight, surgical position, and length of surgery were the reasons they were admitted to the icu intubated overnight.The patient was successfully extubated the following day and had an unremarkable post-operative course.The patient is currently doing well.
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.The fse replaced top left blue pigtail fiber cable on the common compute controller (ccc).The fse replaced the top left fiber cable for the fiber port, which resolved the issue.The fse restarted the system three times, performed system verification, and confirmed that the system was ready for use.The system was tested and verified as ready for use.The complaint was confirmed based on field evaluation.

• Brand Name: daVinci 5
• Common Device Name: Vision Side 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: 50175050
• Report Number: 2955842-2026-34529
• Device Sequence Number: 18613655
• Product Code: NAY
• UDI-Device Identifier: 00886874119662
• UDI-Public: (01)00886874119662
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K232610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 380746-46
• 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: 07/13/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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; Hospitalization
• Patient Sex: Unknown