MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; SURGEON SIDE CONSOLE, SMART PEDALS

Model Number 380677-04

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse was able to isolate the issue by having the customer power up in standalone.Upon arrival, the fse swapped dvi cables at the pmsc with no vision staying on right eye.The monitor was checked by trying a new monitor which showed an image.The fse replaced and aligned a new high resolution stereo viewer (hrsv) monitor to resolve the issue.The hrsv monitor has been returned for evaluation; however, the device evaluation has not been completed.A follow-up mdr will be submitted post engineering evaluation or if additional information is received.A review of the site's complaint history does not reveal any related complaints involving this product or this event.No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that there was no image in an eye of the ssc.System unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted surgical procedure, one of the eyes was not working in the surgeon side console (ssc).The customer contacted technical support and noted that the vision side cart (vsc) had vision in both eyes even though the ssc did not.The technical support engineer (tse) then asked if they had tried swapping scopes, power cycling, hard cycling, and verifying blue fibers.The customer stated that or staff had tried all that with the clinical sales representative (csr) who was on site and did not wish to do so again as surgeon was working through the issue.System logs were not available as the system was not connected to onsite.The site was continuing the procedure using one eye in the ssc.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

D02: the high resolution stereo viewer (hrsv) monitor has been returned and evaluated by the failure analysis (fa) team.Failure analysis investigations confirmed the customer reported complaint.The unit was powered on, there was no backlight, and it failed the backlight calibration test.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• 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: 13091396
• MDR Text Key: 287017628
• Report Number: 2955842-2021-11820
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

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
• Device Operator: Health Professional
• Device Model Number: 380677-04
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 04/13/2022
• Supplement Dates FDA Received: 05/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.