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

Model Number	380610-21
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure, the clinical sales representative (csr) contacted the technical support engineer (tse) and reported that one surgeon side console (ssc1) was having issue with the touchpad and the high-resolution stereo viewer (hrsv).The ssc1 touchpad was flickering continuously and the hrsv vision displayed intermittent green color.The site was proceeding surgery with another surgeon side console (ssc2).The csr also reported that there is purple color image on ssc2 touchpad.The tse suggested customer to reset blue fiber cable (bfc) connection after surgery.The site rebooted and reseated the bfc cable, but issue was still same.The procedure was completed with surgeon console 2 (ssc2) with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and confirmed that the issue happened on same procedure but on different consoles in dual console system.Ssc 1 had issue on touchpad and hrsv.Ssc 2 have only issue with touchpad as per fse notes.The surgery was completed robotically with ssc 2.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting touchpad issue, an investigation is in progress 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 was able to reproduce the reported issue.The fse replaced the touchpad screen and the high resolution stereo viewer (hrsv) to correct the reported problem.The system was tested and verified as ready for use.The complaint regarding touchpad issue was confirmed based on the field evaluation, which indicates that the device did contribute to the customer reported issue.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive da vinci products to perform failure analysis.The touchpad was returned for failure analysis, but the reported failure could not be replicated or confirmed.The touchpad was installed into the printed circuit assembly (pca) system during in-house failure analysis.The surgeon console powered up normally and showed a good image.This part passed communication, calibration, touchscreen buttons functional, and power cycles for one hour without flickering.The visual inspections show the touchpad was in good condition.The hrsv was returned for failure analysis, and the reported failure was confirmed.During in-house failure analysis, the monitor was installed on the test system.The hrsv started up without any errors.The image quality was sharp, with no noise, and not tinted.The visual inspections showed that the hrsv unit has physical damage on the side of the unit where the screw is attached.
Additional Manufacturer Narrative
The failure analysis (fa) was updated based on the original equipment manufacturer (oem) evaluation.The oem performed the final test on the high resolution stereo viewer (hrsv) and found that the vertical lines were present in the tft panel.The hrsv has been scrapped.The oem performed the final test on the touchpad and found that the compact flash (cf) card failed to boot up.The cf card was phased out.
Event or Problem Description
Refer to h10/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
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 17597214
• Report Number: 2955842-2023-17906
• Device Sequence Number: 20466781
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2023

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: 380610-21
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 09/12/2023; 10/11/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/12/2023; 11/06/2023
• 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: Male