• 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 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS

  • 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 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDAVINCI XI
Type of DeviceSURGEON 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 Key13058430
MDR Text Key283302259
Report Number2955842-2021-11790
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110744
UDI-Public(01)00886874110744
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
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 Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-23
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/22/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
-
-