MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI SI VISION SYSTEM CART; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number VS3000

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2019

Event Type  malfunction  

Event Description

Doctor was doing a thymectomy case robotically.There was a fault before the case started that was resolved and was a result of a cable not being seated properly.During the case there were three more faults (309) on the davinci system.The system was in use and docked in the patient.Rn was already on the phone with dv stat (davinci troubleshooting) and working on the issue.We have a process called emergency undocking when we have a fault that is unrecoverable and the robot is in use.We switched video to our storz system for visualization of instruments and unclamped any instruments that needed to be unclamped and removed them and rebooted the system.This same error occurred two more times and same process followed.On the third time of reboot i disconnected the dvi cable in the robot vision tower since this was thought to be a possible cause of a 309 fault in the past.After reboot, doctor finished the case without faults.Basically the extra monitors in the room will not show image without the dvi cable connected but there is image on the vision tower.No harm caused by device failure.Davinci field engineer was also dispatched to look at the robot.

• Brand Name: DA VINCI SI VISION SYSTEM CART
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 9426205
• MDR Text Key: 169514555
• Report Number: 9426205
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VS3000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12410 DA