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	12/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted total benign hysterectomy surgical procedure, the customer did not have vision in the right eye of the surgeon side console (ssc).An intuitive surgical, inc.(isi) technical support engineer (tse) did not observe any system log issues related to reported problem.The customer confirmed they had left and right eye video on the vision side cart (vsc).The customer performed a power-cycle of the system and a hard power-cycle of the ssc.The customer then powered back up with no change and confirmed they still had left and right eye video on the vsc.The customer proceeded with an additional power-cycle of the system, a hard power-cycle of ssc, and reseated the blue fiber cables during the power-cycle.The customer powered the system back on with no change.The customer was unsure of how the surgeon was going to proceed.An isi field service engineer (fse) was to follow up.There was no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the procedure was completed using the same surgeon console with no patient injury.The surgeon put an eye patch on her right eye and completed the procedure 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 confirmed the right eye was black, with no image, on the surgeon side console (ssc).The fse replaced the monitor to resolve the issue.The system was tested and verified as ready for use.Isi received the parts involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation replicated and confirmed the reported complaint.Fa found electrical, fiber optic defects, and component or modular issue.The root cause was attributed to component failure.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.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.

• 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: 16971749
• Report Number: 2955842-2023-14282
• Device Sequence Number: 6537404
• Product Code: NAY
• UDI-Device Identifier: 00886874110782
• UDI-Public: (01)00886874110782
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/17/2020

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: 12/30/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 05/22/2023
• 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: Female