• 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 380677-10
Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2018
Event Type  malfunction  
Manufacturer Narrative
Isi received the units involved with this complaint, however, the failure analysis investigation is still in progress therefore the root cause of the customer reported failure has not been determined. A follow up mdr will be submitted once the failure analysis has been completed and/or additional information is received. This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure. Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.
 
Event Description
During a da vinci-assisted left pyeloplasty procedure; the left eye was lost on the surgeon side console (ssc) high resolution stereo viewer (hrsv) with error 45312. A technical support engineer advised to power cycle but the issue persisted. The surgeon made the decision to convert the planned procedure to another da vinci system. The procedure was completed and no patient harm, adverse outcome or injury was reported. A field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The reported complaint was confirmed based on the field evaluation. The left and right monitors were replaced to resolve the issue.
 
Manufacturer Narrative
Intuitive surgical, inc (isi) received the high resolution stereo viewers (hrsv) involved with this complaint and completed the device evaluations. Failure analysis investigation confirmed the reported failure on both units. One unit would intermittently have no video and the other loses video when it gets warm.
 
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
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale 
4085232100
MDR Report Key7449077
MDR Text Key106385996
Report Number2955842-2018-10154
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-