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

Model Number	380689-03
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted inguinal hernia repair surgical procedure, the left eye in the surgeon side console (ssc) was black.The customer stated that there were two (2) consoles in the room, and there was no issue with the other console, where the surgeon was working.The intuitive surgical, inc.(isi) technical support engineer (tse) viewed the system logs and there were no errors noted.The tse advised the customer to power-cycle the system.The customer stated that they were going to have to wait, as the surgeon was proceeding, "as is." the tse then recommended to the customer that when they get the chance, for them to power-cycle the system and check both eyes in the suspect console, to confirm both were working.The customer agreed and requested an isi field service engineer (fse) to follow up.The customer also stated that the suspect console was the one closest to the light source control box.The customer site proceeded with the case.The procedure was completed with no reported patient harm, injury, or adverse outcome.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the high resolution stereo viewer (hrsv) to resolve the issue.The system was tested and verified as ready for use.Isi received the hrsv involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed and replicated the customer reported complaint, "left eye in console is black." fa noted the root cause was attributed to a component failure.

• 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: 17047436
• Report Number: 2955842-2023-15593
• Device Sequence Number: 12023105
• Product Code: NAY
• UDI-Device Identifier: 00886874110782
• UDI-Public: (01)00886874110782
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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: 380689
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 06/02/2023
• 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