MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; SURGEON SIDE CONSOLE

Model Number	380610-10
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was able to reproduce the issue and replaced the high-resolution stereo viewer (hrsv).The system was tested and ready for use.As of the date of this report, the hrsv has not yet been received by isi for evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, the surgeon side console (ssc) left eye was black and had reconnected camera cables three times without success.Site also reseated blue fiber cable (bfc), but the issue remained.The intuitive surgical, inc.(isi) technical support engineer (tse) requested if the customer was able to see left eye on vision side cart (vsc) touchscreen and that was the case and guided caller to power the system off, reconnecting bfc on ssc, and power the system back on.The tse said the customer should check whether the da vinci logo was present on ssc left eye during power on sequence, however, left eye was completely black during the whole process.The tse then guided caller to power cycle the system again, unplugging ssc while it was off, with same result.The procedure was converted to a traditional laparoscopic surgery.There was a procedure delay between 15-30 minutes.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) contacted the distributor and obtained the following information: the surgeon converted the procedure to laparoscopic surgery because the surgeon did not have 3d vision at surgeon's console.The conversion did not result in increasing the port size incision or adding additional ports.There was no injury to the patient.
Additional Manufacturer Narrative
The high resolution stereo viewer (hrsv) has been evaluated by the failure analysis (fa) team.Fa was able to confirm and reproduce the reported complaint.In system logs, no data was found to indicate that the fault had occurred in the field.During visual inspection, fa found no issue related to the report issue.The monitor was installed onto a golden system (is 3000) where the failure was triggered no image in left eye indicating fault on the monitor.As a result of these findings, fa was able to conclude that the monitor was found to be the root cause of the reported event.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: SURGEON SIDE CONSOLE
• 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: 20769976
• Report Number: 2955842-2024-22381
• Device Sequence Number: 7914556
• Product Code: NAY
• UDI-Device Identifier: 00886874110683
• UDI-Public: (01)00886874110683
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K081137
• 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
• Report Date (Section B): 10/31/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 380610-10
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 02/08/2025; 03/18/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 03/06/2025; 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2010
• 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
• Patient Sex: Male