• 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 INTUITIVE SURGICAL DAVINCI ROBOT VESSEL SEALER

  • 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 INTUITIVE SURGICAL DAVINCI ROBOT VESSEL SEALER Back to Search Results
Model Number 410322
Device Problems Device Operates Differently Than Expected (2913); Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/02/2017
Event Type  malfunction  
Event Description
The vessel sealer was placed in arm 1 during the procedure. After approximately 10 minutes of use, we had a recoverable fault stating that we had a vessel sealer malfunction and the blade may be exposed. The blade was exposed. We removed the vessel sealer and replaced with a new one. No harm to patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTUITIVE SURGICAL
Type of DeviceDAVINCI ROBOT VESSEL SEALER
Manufacturer (Section D)
INTUITIVE SURGICAL
sunnyvale CA
MDR Report Key7002753
MDR Text Key91234861
Report NumberMW5073128
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number410322
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-