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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL DAVINCI ROBOT SYSTEM SURGICAL COMPUTER

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INTUITIVE SURGICAL DAVINCI ROBOT SYSTEM SURGICAL COMPUTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597); Vascular Dissection (3160)
Event Date 07/01/2014
Event Type  Injury  
Event Description
Statute of limitations ends friday (b)(6) 2017. Please help! (b)(6) attorney (b)(6) has been looking all over the country for an open class action lawsuit or someone who has done sufficient research on the davinci robot to help. I had a hysterectomy using the davinci robot on (b)(6) 2014. On (b)(6) 2014, the vaginal cuff tore open, along with a vein. I lost significant blood. So much that one of the trauma nurses and my mother had me sign a statement saying who would get my daughter and witnessed it. The nurse who witnessed my signature, (b)(6), told me later that she was shocked to see me alive. In all her years as a trauma nurse, she had never seen anything like it. She said i was birthing baby sized blood clots. After surgery, i was sent home without blood because my blood count didn't reflect the blood loss yet. (b)(6), i was too weak to hold my head up. When i got to (b)(6) hospital er department, the top number for my blood pressure was in the 50's and the bottom number was in the 30's several staff tried for hours (not sure how many) to locate a vein to start an iv and couldn't. The pain in my head was excruciating- and the er could not give me enough pain killer in shots to get the pain under control. I was taken to ultrasound to locate a vein and install a picc line to my heart. I had transfusions (b)(6) as an inpatient, then came back daily through the (b)(6) for additional transfusions. Since that traumatic experience, i have suffered from additional mental health challenges, get confused easily, and have struggled to take care of myself and my daughter. A little over a week ago, i found out i have brain damage based on results of neuropsychological exam. Apparently, a brain scan could identify what damage is from external force and what's caused by anoxia. Regardless of what those results could say, i have not been the same since. My daughter now suffers from ptsd as well. I was home alone with my daughter (in the country) when the blood started flowing. She was 4 at the time and thought she was watching her mommy bleed to death. There's more. Hoping this is enough to help!.
 
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Brand NameDAVINCI ROBOT
Type of DeviceSYSTEM SURGICAL COMPUTER
Manufacturer (Section D)
INTUITIVE SURGICAL
MDR Report Key6680514
MDR Text Key78982883
Report NumberMW5070734
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 06/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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

Patient Treatment Data
Date Received: 06/28/2017 Patient Sequence Number: 1
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