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Not graded by the source2013-10-11FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04345da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE SOMETIME ON 2007. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BLOOD VESSELS WERE CUT WHICH CAUSED INTERNAL BLEEDING
cause not established2955842-2013-04345Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-11FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04361da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE IN (B)(6) 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BOWEL WAS DAMAGE.
cause not established2955842-2013-04361Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-11FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04346da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PARTIAL INTESTINE REMOVAL PROCEDURE ON (B)(6) 2012. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: LARGE HERNIA AT THE SITE OF THE INCISION, PAIN, DISCOMFORT, NAUSEA. HERNIA REMOVAL SURGERY.
cause not established2955842-2013-04346Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-11FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04358da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE IN (B)(6) 2011. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INCONTINENCE, PAIN, BOWEL PROBLEMS, HAD TO HAVE BLADDER SURGERY.
cause not established2955842-2013-04358Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-11FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04354da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE SOMETIME ON 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PATIENT REPORTED INCONTINENCE.
cause not established2955842-2013-04354Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-11FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04338da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI GALL BLADDER PROCEDURE SOMETIME ON 2009 OR 2010. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: LACERATED LIVER.
cause not established2955842-2013-04338Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-11FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04364da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI NEPHRECTOMY PROCEDURE IN (B)(6) 2007 AND HYSTERECTOMY WITH BSO IN (B)(6) 2008. PROCEDURE DATES ARE UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: CHRONIC PAIN, NERVE DAMAGE, PAIN IN SPINE.'
cause not established2955842-2013-04364Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-11FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04363da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE SOMETIME ON 2008. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: URETHRA WAS CUT. CONSTANTS UTE'S, BLADDER INFECTIONS, KIDNEY INFECTIONS AND STOMACH INFECTION.
cause not established2955842-2013-04363Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04214da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PARTIAL HYSTERECTOMY PROCEDURE ON 2007. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SEVERE PAIN IN RIGHT THIGH, MAJOR SCARRING DUE TO DAVINCI, ONGOING PAIN SINCE OPERATION
cause not established2955842-2013-04214Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04224da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROCTECTOMY PROCEDURE ON (B)(6) 2008. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: IMPOTENT, INCONTINENCE OF BOWEL AND BLADDER.
cause not established2955842-2013-04224Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04295da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI STENTS HEART PROCEDURE ON 2006. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: RUPTURED ARTERY
cause not established2955842-2013-04295Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04288da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2012. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: ONE SIDE OF HER STOMACH IS MUCH THINNER THAN THE OTHER, TROUBLE EATING, INCONTINENCE, BOWEL PROBLEMS, SHARP STOMACH PAINS CONSTANTLY, CORRECTIVE SURGERY.
cause not established2955842-2013-04288Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04183da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE SOMETIME IN (B)(6) 2010. EXACT PROCEDURE DATE WAS NOT PROVIDED AT THIS TIME. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PROLAPSED BLADDER & HER WALL WAS STRETCHED WHICH HAD TO BE TACKED UP, SORENESS, BLADDER PAIN, AND BOWELS ARE NOT LOCATED WHERE THEY ARE SUPPOSED TO BE.
cause not established2955842-2013-04183Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04284da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI BARIATRIC SURGERY & HIATAL HERNIA REPAIR IN 2010/2011. EXACT DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: VASCULAR VEIN BEHIND STOMACH WAS NICKED DURING SURGERY. THE PATIENT REQUIRED 8 UNITS OF BLOOD AND 2 UNITS OF PLASMA.
cause not established2955842-2013-04284Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04290da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI STOMACH CANCER PROCEDURE ON 2013. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PAIN, CAN'T EAT, HAS HOLE IN ESOPHAGUS AND PNEUMONIA DUE TO THE OPERATION.
cause not established2955842-2013-04290Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04216da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE SOMETIME IN 2010. EXACT DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: UNCONTROLLABLE INCONTINENCE AND ERECTILE DYSFUNCTION.
cause not established2955842-2013-04216Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04242da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PARAESOPHAGEAL HERNIA PROCEDURE IN 2011. EXACT DATE OF PROCEDURE WAS NOT PROVIDED. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SEVERE PAIN FOR A FEW WEEKS. AFTER SURGERY, COULD NOT SWALLOW, DAMAGE TO STOMACH AND GASTROPARESIS.
cause not established2955842-2013-04242Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04202da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2010. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'NICKED DURING SURGERY WHICH CAUSED INTERNAL BLEEDING, 3 BLOOD TRANSFUSIONS, SOCCER BALL SIZE HEMATOMA'
cause not established2955842-2013-04202Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04272da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE IN 2007. EXACT DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INCONTINENCE AND HAD TO HAVE SURGICAL CORRECTION.
cause not established2955842-2013-04272Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04294da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI CHOLECYSTECTOMY PROCEDURE ON 2010. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: MEDICAL INDUCED COMA, LEAK IN HER BODY RESULTING IN FULL ORGAN FAILURE, PAIN DUE TO HERNIA.
cause not established2955842-2013-04294Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04191da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI GASTRIC BYPASS PROCEDURE SOMETIME IN 2002. EXACT DATE OF PROCEDURE WAS NOT PROVIDED. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY:UTERUS AND CERVIX WERE CUT.
cause not established2955842-2013-04191Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04213da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY SOMETIME ON (B)(6) 2010. EXACT DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: MASS OF BLOOD AND TISSUE COVERED HER TUBES, SEVERE BACK PAIN, SEVERE PAIN IN LEG AND LUMPS IN BOTH HER LEGS.
cause not established2955842-2013-04213Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04193da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2010. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SEVERED URETHRA, DURING OR RIGHT AFTER SURGERY KIDNEYS FAILED, BIG INTENSE BLOCKAGE HAD BACTERIAL INFECTION, NO SPERM PRODUCTION, BURNING SENSATION WHERE URETHRA WAS CUT.
cause not established2955842-2013-04193Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04210da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE SOMETIME IN 2010. THE EXACT PROCEDURE DATE WAS NOT PROVIDED. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: THIS PATIENT LEAKED URINE/WATER FROM NAVAL AND SURGICAL CORRECTION WAS REQUIRED.
cause not established2955842-2013-04210Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04270da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2013. EXACT DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: AFTER SURGERY THE DOCTOR TOLD HER SHE HAD A LARGE ABSCESS AND A BLADDER INFECTION. HOSPITAL TOLD HER THAT BLADDER WAS ENLARGED DIFFERENT OPINIONS WERE GIVEN ON WHAT THEY SHOULD DO BUT WAS GIVEN ANTIBIOTICS AND RELEASED.
cause not established2955842-2013-04270Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04244da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI GALLBLADDER PROCEDURE IN (B)(6) 2012. EXACT PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PATIENT HAD TO BE STITCHED AND HAD TO HAVE DRAIN PUT IN AND WAS HOSPITALIZED FOR A WEEK.
cause not established2955842-2013-04244Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04217da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE SOMETIME IN 2005. EXACT PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INTERNAL BURNING PAIN THAT REQUIRED MEDICATION THAT TOOK ABOUT 8 MONTHS TO HEAL.
cause not established2955842-2013-04217Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04197da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE IN 2012. DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INCONTINENCE, BOWEL PROBLEMS, LEFT LEG SWELLS, PAIN.
cause not established2955842-2013-04197Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04223da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATE CANCER PROCEDURE ON (B)(6) 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SEVERED LEFT NERVE BUNDLE, ERECTILE DYSFUNCTION, INTERNAL BLEEDING.
cause not established2955842-2013-04223Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04230da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE IN 2010. EXACT DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: ABDOMINAL MUSCLE WAS DAMAGED, HAS HERNIA-TYPE EGG-SIZED BULGE IN ABDOMEN AND CONTRACTED (B)(6).
cause not established2955842-2013-04230Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04261da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HERNIA PROCEDURE ON 2010. EXACT PROCEDURE DATE IS UNKNOWN AT THIS TIME. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: THREE ADDITIONAL HERNIAS GREW UNDER THE MESH THAT WAS IMPLANTED IN 2010. SHE HAD MESH SURGERY IN (B)(6) 2013, IN WHICH THEY REMOVED THE THREE HERNIAS THEY ALSO TOOK HER GALLBLADDER. A NEW MESH WAS IMPLANTED.
cause not established2955842-2013-04261Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04204da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI STENT FOR A LEAK IN GALLBLADDER SOMETIME IN 2006. EXACT DATE OF THE DA VINCI PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: IN THE PROCESS OF PUTTING STENT IN, THE PATIENT'S LIVER AND LIVER BILE DUCT WAS CUT BY MISTAKE.
cause not established2955842-2013-04204Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04208da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATE CANCER PROCEDURE IN (B)(6) 2007. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'INCONTINENCE, BOWEL PROBLEMS, SEVERE PAIN, SWOLLEN STOMACH, GAS, LOST FEELING IN LEFT LEG'.
cause not established2955842-2013-04208Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04307da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LETTER FROM THE REPORTER. ACCORDING TO THE LETTER, THE REPORTER WAS IN THE PROCESS OF WRITING A CASE REPORT ON A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC SURGERY (BY ANOTHER PHYSICIAN) AND SUFFERED WHAT APPEARS TO BE AN ELECTRICAL INJURY. DETAILS RELATED TO THE DA VINCI SURGICAL PROCEDURE WERE NOT PROVIDED. ISI ATTEMPTED TO CONTACT THE REPORTER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.
cause not established2955842-2013-04307Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04227da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE IN 2005. EXACT PROCEDURE DATE IS UNKNOWN AT THIS TIME. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SEVERE SCAR TISSUE AND NERVE DAMAGE.
cause not established2955842-2013-04227Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04276da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI CHOLECYSTECTOMY PROCEDURE ON 2004. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BILE LEAK, AFTER SURGERY GALLBLADDER HAD TO BE REPAIRED, LIVER AND LUNG POKED DURING 2ND SURGERY, INTERNAL BLEEDING, SEPSIS AND COLITIS
cause not established2955842-2013-04276Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04256da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE IN 2010. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: UNEXPLAINED PAIN A FEW MONTHS AFTER SURGERY. THE DOCTOR DISCOVERED THAT SHE HAD A HEPATIC ADENOMA RUPTURE IN HER LIVER CAUSING A 13 MASS. DOCTOR BELIEVED THERE WAS ANOTHER MASS. THE SURGERY FOR MASSES TRIGGERED HER LUPUS WHICH WAS DORMANT AT FIRST
cause not established2955842-2013-04256Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04231da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI COLON RESECTION PROCEDURE ON 2011. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BOWEL COMPLETELY OPENED UP, LUNGS HARMED, CURRENTLY ON OXYGEN, BROKEN TEETH.
cause not established2955842-2013-04231Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04225da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE SOMETIME IN 2011/2012. EXACT DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: AFTER SURGERY, THE PATIENT DEVELOPED A NECROTIZING FASCIITIS AT INCISION SITE. SURGEON HAD TO REMOVE A BIG PORTION OF HER STOMACH. PATIENT WAS SENT HOME WITH A WOUND VAC FOR 6 MONTHS. THE STAPH INFECTION IS SEEDED IN HER BODY.
cause not established2955842-2013-04225Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04253da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PARTIAL PANCREAS REMOVAL PROCEDURE IN 2008. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INFECTION AND HAD SURGICAL CORRECTION.
cause not established2955842-2013-04253Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04205da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE SOMETIME IN 2011. THE EXACT DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: THE PATIENT WAS BLEEDING HEAVILY AND HAD TO HAVE SURGICAL CORRECTION.
cause not established2955842-2013-04205Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04182da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE SOMETIME IN JANUARY 2010. EXACT PROCEDURE DATE IS UNKNOWN AT THIS TIME. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: POOLS OF URINE IN ABDOMEN, SEVERE PAIN.
cause not established2955842-2013-04182Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Death reported2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-05132da Vinci Surgical System
da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT SUDDENLY DIED TWO DAYS LATER ON (B)(6) 2013 JUST BEFORE DISCHARGE FROM THE HOSPITAL. ACCORDING TO THE SITE'S ROBOTICS COORDINATOR, THE CAUSE OF THE PATIENT'S DEATH WAS IDENTIFIED AS A PULMONARY EMBOLISM. ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE RISK MANAGER (RM) FROM THE SITE. THE RM INDICATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE RM WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ON (B)(6) 2013, ISI ALSO CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS INFORMED OF THE REPORTED EVENT BY THE ROBOTICS COORDINATOR. ACCORDING TO THE CSR, THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE INITIAL REPORTER OF THIS COMPLAINT, THE ROBOTICS COORDINATOR, TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE ROBOTICS COORDINATOR AS OF THE DATE OF THIS R
cause not established2955842-2013-05132Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04199da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATE CANCER PROCEDURE ON 2007. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'TEAR IN BLADDER WHICH REQUIRED HIM TO HAVE (5) DRAIN TUBES IN ABDOMEN, INCONTINENCE'.
cause not established2955842-2013-04199Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04229da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATE CANCER PROCEDURE ON (B)(6) 2013. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'BURN TO SKIN AT THE INCISION SITE THAT IS STILL HEALING NOW, INCONTINENT IMMEDIATELY AFTER CATHETER WAS REMOVED, PAIN.
cause not established2955842-2013-04229Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04282da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012. EXACT DATE OF PROCEDURE WAS NOT PROVIDED. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY:CATHETERIZE FOR SIX WEEKS AND UNABLE TO PASS URINE.
cause not established2955842-2013-04282Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04251da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TUBAL LIGATION, TUBAL LIGATION REVERSAL, HYSTERECTOMY PROCEDURE ON IN 2005, 2007,2008, AND 2013. EXACT PROCEDURE DATES IS UNKNOWN AT THIS TIME. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: HAD ENDOMETRIOSIS, PAINFUL MASS GREW ON HER RIGHT SIDE, HAD TO REMOVE ENTIRE ABDOMINAL MUSCLE AND PUT A MESH SO THERE WAS NO HOLE.
cause not established2955842-2013-04251Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04212da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HERNIA REPAIR SOMETIME IN 2008. EXACT DATE OF SURGICAL PROCEDURE IS UNKNOWN AT THIS TIME. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PAIN, NERVE DAMAGE, INFECTION, INCONTINENCE, DAMAGED LIVER, NUMBNESS IN GROIN, A PLATE WHICH WAS PUT IN DUE TO THE HERNIA REPAIR WAS MOVING AND PATIENT HAD SCAR TISSUE.
cause not established2955842-2013-04212Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04273da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PARTIAL COLECTOMY IN 2011. EXACT DATE OF PROCEDURE IS UNKNOWN AT THIS TIME. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INTESTINES TWISTED DURING SURGERY, PERSISTENT DIARRHEA AND PAIN AFTER SHE EATS.
cause not established2955842-2013-04273Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Death reported2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04195da Vinci Surgical System
da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON 2009 OR 2012. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DURING SURGERY A HOLE WAS CUT IN STOMACH. PATIENT BECAME SEPTIC AND F/U SURGERY DONE. CLIENT IS DECEASED.
cause not established2955842-2013-04195Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗