• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTUITIVE SURGICAL, INC. DA VINCI SI VISION SYSTEM CART SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDA VINCI SI VISION SYSTEM CART
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key9426205
MDR Text Key169514555
Report Number9426205
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received12/06/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVS3000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/22/2019
Event Location Hospital
Date Report to Manufacturer12/06/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-