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

Model Number 380677-16

Device Problem No Display/Image (1183)

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

Event Date 03/30/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the right eye of the surgeon side console (ssc) had no image.The intuitive surgical, inc.(isi) field service engineer (fse) was onsite.The fse was unable to replicate the right eye going out.The fse noted that the left eye went out during troubleshooting.The tse reviewed logs and noted errors 119 and 48259 on the ssc.Isi followed up with the initial reporter and obtained the following additional information: the issue was identified during the case.The ports were placed and the procedure was completed with no issue.The customer had a dual system set up.The issue was noted on the ssc that a resident was working on.The ssc that the surgeon was sitting at had no issues were noted.

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) performed further investigation regarding the reported complaint.The reported issue was confirmed based on the field evaluation.The isi fse revealed that the monitors would go out intermittently.The isi fse replaced the personality module surgeon console (pmsc) and generic power distributor (gpd).The system was tested and verified as ready for use.Isi has received the pmsc and the gdp.Failure analysis has been completed for the gpd, but is ongoing for the cfg pmsc.A follow-up mdr will be submitted when failure analysis has completed the investigation of the second component.The gpd was installed on a test system and was powered on without error.A vision test was performed and verified vision quality.Both monitors showed a clear image with no issues.The system ran five power cycles and a five minute sine cycle with no issues.There was no trouble found with the component.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 occurred during the surgical procedure that were related to the reported complaint.This complaint is reportable due to the following: the the system was not in optimal state after the start of the procedure due to no image seen in one eye of the surgeon side console.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a procedure change.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the personality module surgeon console (pmsc) involved with this complaint and completed the device evaluation.Failure analysis investigation could not replicate the customer reported complaint.The pmsc was installed and tested on the printed circuit assembly (pca) test system.The system started up without any error, with good image on both eyes.The pmsc ran 150x power cycles with this module, all passed with good picture on both eyes.The pmsc remained on the test system in normal operation over 10 hours while testing other boards, there is no issue reported.The reported issue could not be replicated.

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: 14250954
• MDR Text Key: 290469299
• Report Number: 2955842-2022-11327
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-16
• Device Catalogue Number: 380677
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES