FDA Adverse Event Injury Summary report: N

INTUITIVE DA VINCI ROBOT

MDR report key: 3983518 · Received August 1, 2014

Report

Report Number
MW5037620
Event Type
Injury
Date Received
August 1, 2014
Date of Event
June 17, 2013
Report Date
May 28, 2014
Manufacturer
INTUITIVE
Product Code
NAY
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

(B)(6) 2013 - DA VINCI ROBOTIC HYSTERECTOMY. (B)(6) - BACK TO WORK. SEVERE PAIN, CONTINUED SEVERE PAIN. SURGEON'S OFFICE TOLD ME TO SEE UROLOGIST. LAB WORK POSITIVE FOR E COLI AND PSEUDOMONAS AERUGINOSA. FOR MONTHS FOLLOWING CONTINUED PAIN/SEVERE. INFECTIOUS DISEASE DOCTOR - POSITIVE INFECTIONS. (B)(6) 2013 NEUROLOGIST: ABNORMAL EMG - MRI'S ABNORMAL. LEFT HIP LABRUM TEAR - MULTIPLE DISC HERNIATIONS. DR (B)(6) REFERRED TO PAIN MANAGEMENT NEUROLOGIST AT (B)(4) - NERVE BLOCK INJECTIONS. CONCLUSIONS: ILIOINGUINAL NERVE ENTRAPMENT DAMAGE/INJURY. GENITAL FEMORAL NERVE DAMAGE/ENTRAPMENT/COMPRESSION INJURY. THIS ROBOTIC DA VINCI SURGERY HAS LEFT MY BODY IN DISASTROUS PAIN EVERYWHERE. MY INSIDE/INTERNAL BODY BURNS AND IN SEVERE PAIN EVERYWHERE INCLUDING SURGICAL SITE, GENITALIA, RECTAL, ARMS, SHOULDERS. WEAKNESS AND BURNING SENSATION. THIS HAS BEEN CATASTROPHIC AND DEVASTATING. IT IS ALSO KNOWN (I NOW KNOW) THAT CERTAIN BODY TYPES ARE NOT GOOD CANDIDATES FOR ROBOTIC. I AM VERY SLENDER AND RETRACTORS TOO LARGE FOR MY BODY. ALSO POSITIONING FOR GYNECOLOGICAL SURGERIES IS DANGEROUS CAUSING INJURIES OR FATALITIES. TRENDELENBURG AND LITHOTOMY POSITIONS ARE SERIOUSLY DANGEROUS. DA VINCI ROBOTIC HYSTERECTOMY. I HAD A DAVINCI ROBOTIC HYSTERECTOMY ON (B)(6)2013. I SUFFERED SEVERE INJURIES FROM THIS DEVICE AND THE INCOMPETENT SURGEON USING THE OVER-PROMOTED DEVICE WHICH 'INTUITIVE' AND HOSPITAL CONSIDER 'MINIMALLY INVASIVE'. MY INJURIES ARE AS SUCH: 'ILIOINGUINAL NERVE DAMAGE- GENITAL FEMORAL NERVE DAMAGE I PERIPHERAL NERVE DAMAGE. MULTIPLE DISC (SPINE) HERNIATIONS, LABRUM TEAR AT LEFT HIP. RIGHT ARM INJURY I PAIN AND BURNING SENSATION THROUGHOUT MY ENTIRE PELVIS, ANUS, BUTTOCKS, LEG WEAKNESS, GENERAL WEAKNESS, AND BURNING SENSATION PAIN THROUGHOUT ENTIRE BODY. THE PAIN IS SEVERE AND RELENTLESS. CURRENTLY UNDER NEUROLOGICAL CARE OF NERVE BLOCK INJECTIONS FOR TEMPORARY RELIEF TO LIFE LONG IRREVERSIBLE PAIN AND DAMAGE TO MY ANATOMY. WAS ALSO INFECTED DURING SURGERY WITH PSEUDOMONAS AERUGINOSA AND ECOLI. I CONTINUE TO BE PLAGUED BY MULTIPLE HOSPITAL ACQUIRED BACTERIAS. THESE DAVINCI ROBOTIC SURGERIES, THE DOCTORS AND HOSPITALS USING THEM ARE A THREAT AND DANGER TO ALL PATIENTS UNDERGOING THESE PROCEDURES ROBOTICALLY. ALL FOR THE PROFIT OF THE DOCTORS, HOSPITALS AND OF COURSE THE MANUFACTURER, INTUITIVE. HOW THE FDA ALLOWS SUCH CATASTROPHIC EVENTS TO CONTINUE IS BARBARIC AND UNFATHOMABLE. THE INCIDENTS AND DANGERS ARE COMPLETELY UNREPORTED OR UNDER-REPORTED. WHY DOES THE FDA ALLOW THIS? THERE IS ENOUGH PROOF EVEN WITH THE MINIMAL AMOUNTS OF INCIDENTS REPORTED TO PUT A STOP TO THIS DEVICE. DOES THE FDA CARE ABOUT THE PATIENTS OR HOSPITAL PROFITS? I THINK THE LATTER. I AM APPALLED THAT ON THE INTERNET, TELEVISION, AND ALL OTHER SOURCES OF MEDIA THAT IT IS PARADED AS 'MINIMALLY INVASIVE' INSTEAD OF THE TRUTH WHICH IS THAT IT IS LIFE THREATENING, AND ZERO MEDICAL DATA THAT THIS DEVICE PROVES TO BE ANY MORE EFFECTIVE OR LESS INVASIVE THAN CONVENTIONAL SURGERIES. THE DOCTOR GETS TO SIT INSTEAD OF STANDING!! THAT IS THE BENEFIT. I WILL CONTINUE AS BEST I CAN TO BRING AWARENESS TO OTHERS IN THE MEDIA AS TO THE HYPE AND FALSE ADVERTISING ON ROBOTIC SURGERY. WHERE IS THE INTEGRITY AND CARE OF THE FDA AND HOSPITALS THAT IS SUPPOSED TO KEEP THE PUBLIC AND PATIENTS OUT OF DANGER? I AM DEMANDING AN INQUIRY AS TO MY PERSONAL DEBILITY AND INJURIES AS WELL AS THAT OF OTHERS. I DO EXPECT TO HEAR BACK FROM THE FDA, FOR I WILL CONTINUALLY BE CHECKING AND HAVE SENT THIS LETTER BY CERTIFIED MAIL SO THAT THERE ARE NO EXCUSES IN RECEIVING OR LOST MAIL. THIS EVENT TOOK PLACE AT (B)(6) MEDICAL CENTER. SURGEON DR (B)(6) RECOMMENDED BY DR (B)(6). BOTH OVER-PROMOTERS OF THE DEVICE. DO YOU THINK THEY MAKE A BIGGER PROFIT OR KICKBACK, OR ARE THEY NOT PROFICIENT IN THE ROBOTIC FIELD, OR ARE THEY JUST SIMPLY INCOMPETENT DOCTORS FULL OF GREED, EGO, AND PRESTIGE?

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
451539 INTUITIVE DA VINCI ROBOT ROBOT NAY INTUITIVE UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 55 YR Other| S MAGNESIUM| KLONOPIN| OMEGA 3| SYNTHROID| VIT D3| VIT E| VERAPAMIL| ADVIL