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

Model Number	380689-03
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The isi fse went on site and identified error 121 in the logs.The isi fse observed that the right eye was blinking intermittently in the high-resolution stereo viewer (hrsv), and the right hrsv monitor failed to reach the desired brightness within five minutes.The isi fse replaced the right hrsv.The system was tested and verified as ready for use.A return material authorization (rma) has been issued requesting to have the isi device returned; however, at the time of this report, the product has not been received.
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, the customer contacted the intuitive surgical, inc.(isi) technical support engineer (tse) and reported that the right eye vision was blinking.The site was not able to reboot the system.The procedure was completing as planned with no reported injury.
Additional Manufacturer Narrative
The high resolution stereo viewer (hrsv) was returned for failure analysis, analyzed and found to have no failure.The monitor was installed on our printed circuit assembly (pca) test system.The unit started up without any errors.The image quality was sharp, no noise, and not tinted.The system idled for 1 hour and visually verified that there were no issues.The complaint was not confirmed based on the field evaluation/failure analysis.
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: 20305185
• Report Number: 2955842-2024-19917
• Device Sequence Number: 12668488
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2024

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/19/2024
• 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