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

Model Number	380689-02
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the vision was not clear in the surgeon side console (ssc).The vision side cart (vsc) touchscreen vision was clear.The customer proceeded with the procedure in that condition.An intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the system logs and noted no errors in the system logs.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: there were no troubleshooting steps performed during procedure, and the procedure was completed robotically with degraded vision.
Additional Manufacturer Narrative
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 confirmed that the left high resolution stereo viewer (hrsv-3) monitor image was deteriorated, making vision blurry.The fse replaced the hrsv monitor to resolve the reported issue.The system was tested and verified as ready for use.The complaint was confirmed based on the field evaluation, which indicates that the device did contribute to the customer reported issue.A return material authorization (rma) was issued to the customer requesting to have the intuitive device returned.However, isi has not received the product involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted if the product is returned (post failure analysis evaluation) or if additional information is received.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) received the high resolution stereo viewer (hrsv) monitor involved with this complaint to perform failure analysis (fa).The high resolution stereo viewer (hrsv) monitor was analyzed, and the reported complaint was confirmed.The hrsv was installed on an in-house test system and started up without any errors.The image quality was slightly blurry compared to the other test fixture monitor.
Event or Problem Description
Refer to h10/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
• 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: 17981195
• Report Number: 2955842-2023-19466
• Device Sequence Number: 2491658
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: 380689-02
• 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): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/05/2023
• 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: Unknown