MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ENDOSCOPE

Model Number	470027-62
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The 30-degree endoscope was returned to intuitive surgical, inc.(isi) for failure analysis (fa).During functional testing, it failed to provide a video due to an electrical communication failure and displayed color bars in the left eye.Additional unrelated observations not reported by site: cracks or holes in the silicone around the circuit board.A system log review did not reveal any system-related errors that would have caused or contributed to the reported event.
Event or Problem Description
It was reported that during a da vinci-assisted partial nephrectomy, the customer experienced an error and all vision with the system was lost while using the 8mm 30-degree endoscope.Several attempts were made to clean the endoscope connector to no avail.Due to the unavailability of a back-up 30-degree endoscope, the procedure was converted to a radical nephrectomy because the partial nephrectomy could no longer be performed safely and oncologically correct with the 0-degree endoscope that was available to continue.Because this occurred during warm ischemia, it was not possible to convert the procedure to laparoscopic due to the time needed to bring in laparoscopic towers and set up the laparoscopic instruments.There was a 150 ml of blood loss for the entire procedure, and blood was lost due to the lack of vision experienced.The procedure was completed robotically with a greater than 30-minute procedural delay.The surgeon is concerned of late renal function decline because of the procedural modification.

• Brand Name: NONE
• Common Device Name: ENDOSCOPE
• 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: 21865883
• Report Number: 2955842-2025-15515
• Device Sequence Number: 7898174
• Product Code: NAY
• UDI-Device Identifier: 00886874112212
• UDI-Public: (01)00886874112212
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K171426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470027-62
• Device Catalogue Number: 470027
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female