• 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 S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

  • 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 S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS2000 A51P8
Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc (isi) has received the high resolution stereo viewer (hrsv) involved with this complaint and completed the device evaluation. Failure analysis investigation confirmed the reported failure. The unit was powered up and the image on left monitor consistently lost. 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
It was reported that during a da vinci-assisted surgical procedure, the left eye of the high resolution stereo viewer (hrsv) in the surgeon side console (ssc) was lost with no alarm or error. The left and right images could be seen on the vision side console, however, the ssc issue persisted after power cycling. The surgeon made the decision to complete the procedure using one eye. The planned surgical procedure was completed under the conditions reported and no patient harm, adverse outcome or injury was reported. An intuitive surgical, inc. (isi) technical field specialist (tfs) was dispatched to the facility and was able to reproduce the reported issue. The ssc hrsv was replaced to resolve the issue. The hrsv provides the video image for the ssc.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDA VINCI S SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
950 kifer rd
sunnyvale CA
Manufacturer Contact
tabitha reed
950 kifer rd
sunnyvale, CA 
4085232420
MDR Report Key7065560
MDR Text Key93565792
Report Number2955842-2017-00798
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K063220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation
Type of Report Initial
Report Date 11/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS2000 A51P8
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-