Description of Event or Problem · 1
ON (B)(6) 2010, MY WIFE HAD HYSTERECTOMY DAVINCI ROBOT SURGERY AT (B)(6), DR (B)(6) (OBGYN). SHE WAS DISCHARGED THE NEXT DAY. THAT NIGHT I MADE HER DINNER AND GAVE HER A GLASS OF WATER. SHE ATE THEN FINISHED OFF THE GLASS OF WATER. MINUTES AFTER THAT...EXTREME PAIN! WE WENT TO THE EMERGENCY ROOM BY AMBULANCE. A MEDICAL DOCTOR AT THE HOSPITAL TOOK OVER HER CARE AFTER THE ROBOT DOC SAID THERE WAS NOTHING MORE SHE COULD DO. SHE WENT BACK INTO SURGERY. THE DOCTOR SAID HER BOWEL WAS "PIERCED/BURNED" OUTSIDE OF THE OPERATING FIELD DURING THE SURGERY WITH THE ROBOT. TEN (10) OPEN SURGERIES LATER...SHE LIVES TODAY (MOST DON'T). MADE A COMPLAINT TO THE (B)(6) MEDICAL BOARD - THEY SAID IT WAS CAUSED BY THE "ROBOT" NOT THE DOCTOR. THEY SAY ITS NOT UNCOMMON USING THE ROBOT. I WENT TO THE LOCAL MEDIA TO INVESTIGATE AND WARN THE PUBLIC AND ASKED THEM WHY MY WIFE'S INCIDENT IS NOT LISTED ON THE MAUDE DATABASE BY THE DOCTOR OR THE HOSPITAL. (B)(4) FROM INTUITIVE SURGICAL INC. CALLED MY PHONE 05/29/2013, AND ASKED ME WHAT HAPPENED, WHO THE DOCTOR WAS, ETC. WITHOUT LOOKING AT MY WIFE'S FILE HE INSISTED THAT IT WAS THE DOCTOR'S FAULT AND NOT A SINGLE INJURY HAS BEEN REPORTED AND THAT HE WOULD ADD THE INCIDENT TO THE MAUDE DATABASE. WE HAD NO IDEA WE HAD TO REPORT THE "INCIDENT" TO THE FDA. WE ASSUMED THE HOSPITAL OR DOCTOR WOULD BE MANDATED TO DO SO. AT THE TIME WERE UNDER THE IMPRESSION THAT IT WAS THE DOCTOR'S FAULT. NOW WITH THE 05/08/2013 "URGENT MEDICAL DEVICE NOTIFICATION" ISSUED BY INTUITIVE SURGICAL INC FOR THE 2009 AND 2010 MONOPOLAR PARTS AND NOW I HAVE SEEN THE FDA 483 APPLICATIONS INVESTIGATION DONE, I FEEL MR (B)(4) IS TRYING TO DO WHAT HE SHOULD HAVE ALREADY DONE. UNPLUG THE "ROBOT!".