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

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!.

• Brand Name: DAVINCI ROBOT
• Type of Device: SYSTEM SURGICAL COMPUTER
• Manufacturer (Section D): INTUITIVE SURGICAL
• MDR Report Key: 6680514
• MDR Text Key: 78982883
• Report Number: MW5070734
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 06/28/2017
• 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