FDA Adverse Event Injury Summary report: N

DA VINCI SURGICAL ROBOT

MDR report key: 4190222 · Received October 15, 2014

Report

Report Number
MW5038684
Event Type
Injury
Date Received
October 15, 2014
Report Date
October 15, 2014
Product Code
NAY
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN (B)(6) 2012, I HAD MY BLADDER AND PROSTATE REMOVED WITH THE DA VINCI ROBOT SYSTEM, THE ROBOT FROM THE INTUITIVE SURGICAL INC. SINCE THE SURGERY, I HAVE NEVER BEEN WITHOUT PAIN. SIX MONTHS AFTER THE SURGERY, THE PAIN HAD GOTTEN MUCH WORSE. I WENT TO ANOTHER SURGEON AND HE HAD SEVERAL TESTS ORDERED. AFTER SEEING THE RESULTS FROM SCANS, THE SURGEON THEN SENT ME TO ANOTHER SURGEON, A VERY WELL-KNOWN SPECIALIST AND HE TOLD BE I HAD A HERNIA. I HAVE NOT BEEN SEEING THREE SPECIALISTS AND TWO HAVE TOLD ME IT WAS THE DA VINCI THAT CAUSED THE HERNIA. I ALSO KNOW I AM NOT THE FIRST. THE MAN WHO HAD THE SAME SURGERY BEFORE ME BY THE SAME DOCTOR WAS ALSO LEFT WITH A VERY SIMILAR HERNIA, AND HE IS NOW IN VERY MUCH WORSE SHAPE THAN I AM. HE HAS NOT EVEN LOST A KIDNEY AND IS AFRAID HE IS GOING TO HAVE TROUBLE WITH THE OTHER ONE AND WHEN TALKING TO HIM ON THE PONE RECENTLY, HE SOUNDED VERY UPSET AND VERY SICK. IN TWO YEARS, THIS SURGERY HAS COMPLETELY DRAINED MY WIFE'S AND MY SAVINGS ACCOUNT AND HAS ALSO DESTROYED MY LIFE AS I KNEW IT. MY BIGGEST PROBLEM IS THE INOPERATIVE HERNIA THAT THE DA VINCI ROBOT LEFT ME WITH. WHEN I SAY INOPERATIVE, I MEAN THAT IT IS GOING TO TAKE SOME TIME BEFORE THAT CAN HAPPEN AND IT IS ALSO GOING TO BE AN EVEN BIGGER SURGERY THAN THE FIRST TIME. IT ALSO ENDED SOMETHING THAT MY WIFE AND I ENJOYED NOW AND THEN FOR THE LAST FORTY YEARS. NOW WE ARE IN OUR (B)(6) BUT IT SURE HURTS TO THINK THAT PART OF MY LIFE IS NOW OVER FOREVER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
652827 DA VINCI SURGICAL ROBOT DA VINCI SURGICAL ROBOT NAY

Patients

Seq Age Sex Outcome Treatment
1 62 YR Other| S