MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CAMERA, 0

Model Number	430077-05
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy without lymphadenectomy procedure, the video output was lost approximately 50 minutes into the procedure while using a single port (sp) endowrist 0 degree endoscope.An error message indicated: "the camera should not touch the tissue because the temperature of the endoscope is unknown.".The image reappeared after approximately five minutes, but only colored calibration bars were displayed.An intuitive surgical, inc.(isi) technical support engineer (tse) was consulted.Troubleshooting steps included reconnecting the camera connector, cleaning the contacts, power cycling the system, and removing the camera to allow the lens to cool; however, the issue persisted.An internal camera fault was identified upon review of the system logs and the tse recommended replacing the endoscope.However, a sterile backup camera was unavailable, as it was being reprocessed.The surgeon opted to convert to a da vinci xi multiport approach, located in a different operating room (or).At the time the event occurred, the surgeon was performing dissection of the prostate and a forceps instrument was holding the prostate to provide countertraction.The robotic instruments were removed according to protocol and the incision was sterilely secured.The patient was then transferred to the other or and the procedure was successfully completed on a da vinci xi system.The incident resulted in an extension of approximately 30 minutes or more of operating time.The patient did not experience any post-operative complications and was discharged home.The sp endowrist 0 degree endoscope was reportedly inspected prior to use and no damage was identified at the time.In addition, no warning messages were identified at the time of system setup.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive a single port (sp) endowrist 0 degree endoscope to perform failure analysis.A review of the site's system logs was performed for the reported procedure, and revealed the following possible related errors: camera power failure, camera power warning, communication error between the scope and endoscope controller (ec), and "the left video channel's temperature sensor in the camera in not responding; temperature monitoring will be disabled.".
Additional Manufacturer Narrative
Updated fields: b1, h2 and h11.Corrected data: b1.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Device evaluation: intuitive surgical, inc.(isi) received the single port (sp) endowrist 0 degree endoscope camera for failure analysis evaluation.System log review revealed that the camera had communication failures, including 10 occurrences each of communications error, temperature sensor failure, and power failure; 1 error occurrence of watchdog timeout; and 17 error occurrences of power warning.During in-house testing, these issues could not be replicated.The camera was placed on an in-house system for functional testing and passed all tests, including stereo calibration, endoscope focus, and color recognition.Images were dewarped, free from graininess, noise, and motion blur.The buttons were fully functional and moved intuitively.First edt testing was successful.Leak tests were performed and passed.Inspection of the manifold membrane using a borescope revealed no punctures or tears.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: CAMERA, 0
• 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: 24566255
• Report Number: 2955842-2026-14453
• Device Sequence Number: 8355204
• Product Code: IZI
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K212101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 430077-05
• Device Catalogue Number: 430077
• Device Lot Number: 001088-8614
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 05/07/2026; 09/23/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/17/2026; 05/11/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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: 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 Sex: Male