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

Model Number	380689-03
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
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 the surgeon side console (ssc) high-resolution stereoscopic viewer (hrsv) to resolve the issue.The system was tested and verified as ready for use.Isi did not receive the hrsv involved with this complaint to perform failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted radical cystectomy with ileal conduit surgical procedure, the user observed that the surgeon side console (ssc) high-resolution stereo viewer's (hrsv) left eye was blurry.However, the images from both the right and left eyes on the vision side cart's (vsc) touchscreen were normal.The user received phone assistance from the intuitive surgical, inc.(isi) technical support engineer (tse).The user was instructed to reboot and reseat the blue fiber cable, but the issue persisted.The procedure was converted to laparoscopic surgery.No known impact or patient consequence was reported.Isi followed up with the initial reporter and obtained additional information: the reporter did not know whether port incisions were increased, or additional ports were placed.The reporter did not know whether the patient tolerated the conversion.The system's functionality was checked upon powering the system and no issues were found.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the high resolution stereo viewer (hrsv) involved with this complaint to perform failure analysis.The hrsv was installed and tested on the in-house system.The hrsv started up and failed without video on the display.It was observed that the whole back cover of the hrsv was oxidized and rusty.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: SURGEON SIDE CONSOLE, RECERTIFIED
• 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: 20197320
• Report Number: 2955842-2024-19169
• Device Sequence Number: 18053317
• Product Code: NAY
• UDI-Device Identifier: 00886874110782
• UDI-Public: (01)00886874110782
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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: 380689-03
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/26/2024
• 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
• Patient Sex: Prefer Not To Disclose