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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL DA VINCI ROBOT; SURGICAL SYSTEM
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INTUITIVE SURGICAL DA VINCI ROBOT; SURGICAL SYSTEM Back to Search Results
Device Problems Use of Device Problem (1670); Defective Device (2588); Device Operates Differently Than Expected (2913)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/20/2007
Event Type  Injury  
Event Description
After having da vinci robotic surgery for prostate removal, i remained in the hospital for 33 days and was given 18 pints of blood.I almost died twice because of internal bleeding and other complications.The surgeon did not even come to see me after the surgery.I spoke with an intern that helped the surgeon with the operation and he told me that at times some of the arms failed to do what it supposed to do.Also, the intern said that he felt that the surgeon did not have sufficient training to perform the operation.I had to have seven more operations to correct the damage to my internal organs because of the defective da vinci robot.If a surgeon does not have the training and if the mfr (intuitive surgical supply) is allowed to manufacture defective surgical devices such as the da vinci robot then they will end up like i did and that means slowly bleeding to death and having to have more extensive surgeries to repair the damages that were caused to me by the use of the da vinci robot and the surgeon.
 
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Brand Name
DA VINCI ROBOT
Type of Device
SURGICAL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL
MDR Report Key6367648
MDR Text Key68836286
Report NumberMW5068186
Device Sequence Number1
Product Code NAY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Disability;
Patient Age75 YR
Patient Weight92
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