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

MAUDE Adverse Event Report: DAVINCI ROBOT FOR LUNG SURGERY 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
 

DAVINCI ROBOT FOR LUNG SURGERY SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Scarring (2061); Deformity/ Disfigurement (2360)
Event Date 03/23/2017
Event Type  Injury  
Event Description
As a patient i was undergoing a robotic left upper lung segmentectomy at (b)(6) performed by (b)(6) using a davinci machine. There were 4 ports used. After the operation my medical records state: "no injuries to patient" yet on my back there are extra scars which are not incision scars. And one of those incisions was not closed completely resulting in a "dent" in my back. The other abnormal scars (i have photos of them) are never explained at any time instead they are dismissed in the records and during my questioning about them to the surgeon, his staff, risk management, and the cancer center. As if none of this happened. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDAVINCI ROBOT FOR LUNG SURGERY
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
MDR Report Key10138090
MDR Text Key194849855
Report NumberMW5094925
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 Patient
Type of Report Initial
Report Date 06/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

-
-