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

Model Number 380677-23

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 11/29/2021

Event Type  malfunction  

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 was unable to duplicate the reported complaint however the error was confirm by reviewing system logs.The fse replaced the right master tool manipulator (mtm) and the remote arm controller (rac) on the surgeon side console (ssc) due to the reported issue.The system was tested and verified as ready for use following the service.Isi received the rac involved with this complaint and completed the device evaluation.Failure analysis (fa) was not able to reproduce the reported failure, but could confirm the error via system logs.Case opened to address error 252.Logs do not show error 252 during last 60 days, but errors 307 and 40019 (307 likely stemming from 252 occurrence) are related to rac function.The rac was installed with a pca test system which launched in maintenance mode to program software, then power cycled 10x and sine cycled for 5 minutes without error.To address the intermittent 307 and 40019 errors, the rcm board will be replaced as a preventative measure.Isi received the mtm involved with this complaint and completed the device evaluation.Failure analysis (fa) was not able to reproduce the reported failure, but could confirm the error via system logs.There were errors 23 and 30 present in field error logs.The unit was tested on in house system and passed normal mode.The unit was also tested on a mini console and passed sensors check, scan mvt, friction, gravity com and sine cycle tests.The esmb pca and main harness will be replaced as a preventative measure.A review of the site's complaint history shows no other complaints for other issues related to this product.No image or video clip for the reported event was submitted for review.A review of the site's system logs for the reported procedure date was conducted by isi technical support when the customer called for support.Investigation revealed multiple errors that were related to the reported complaint occurred during the surgical procedure.Based on the information provided at this time, this complaint is being classified as a reportable event due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) resulted in the procedure being converted.Although there was no patient injury reported, if the reported issue were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted total colectomy surgical procedure, a non- recoverable fault had occurred and all arms were red.The customer had power cycled and the error reoccurred.Intuitive surgical, inc.(isi) technical support engineer reviewed system logs and confirmed errors reported by the right master tool manipulator (mtm) and remote arm controller (rac) on the number two surgeon side console (ssc).Error may indicate failure of the number two ssc -rac, lvds communication to rac or right mtm axis2 failure.Tse recommended the customer to power off and disconnect number two ssc.The system powered on without errors after disconnecting the number two ssc.The procedure continued using number a single ssc with no reported injury.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Rac board was sent to manufacturer for inspection.Manufacturer found the j9 connector had damaged.The rac board will be scrapped.Annex code d02 was added.

• 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: 13058430
• MDR Text Key: 283302259
• Report Number: 2955842-2021-11790
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-23
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES