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3,136 records match for Intuitive Surgical, Inc.

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Not graded by the source2013-10-10FDA MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04283da 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 KIDNEY BIOPSY PROCEDURE ON (B)(6) 2005. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SEVERE INTERNAL PERINEPHRIC HEMATOMA, REQUIRED BLOOD TRANSFUSIONS, NERVE DAMAGE IN RIGHT LEG
cause not established2955842-2013-04283Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04243da 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 OVARY REMOVAL IN 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: AFTER REMOVING THE OVARIES, SHE BEGAN BLEEDING INTERNALLY. PRIOR TO BEING TAKEN OUT OF THE OR, THEY HAD TO OPEN HER UP MANUALLY TO STOP THE BLEEDING. SHE IS NOT SURE WHAT WAS NICKED BUT SHE HAS A LARGE SCAR ABOVE HER GROIN.
cause not established2955842-2013-04243Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04190da 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 REPAIR CONGENITAL URETER PROBLEM SOMETIME IN EITHER 2010 OR 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: BLOOD VESSEL WAS CUT OR RUPTURED.
cause not established2955842-2013-04190Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04233da 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 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: SLICED INTESTINE AND INCONTINENCE. THE PATIENT NOW HAS TO WEAR DIAPERS.
cause not established2955842-2013-04233Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04259da 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 (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 ARTERY IN STOMACH, SURGICAL CORRECTION.
cause not established2955842-2013-04259Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04264da 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. EXACT PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INFECTION SIZE OF A LEMON,SURGERY DONE TO REMOVE INFECTION,PICC LINE PLACED TO DELIVER INTRAVENOUS ANTIBIOTICS.
cause not established2955842-2013-04264Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04296da 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 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: IMPOTENCE, INCONTINENCE, BOWEL PROBLEMS, HERNIA PROBLEM
cause not established2955842-2013-04296Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04238da 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) 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PROSTATE BECAME ATTACHED TO BLADDER, SURGICAL CORRECTION
cause not established2955842-2013-04238Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04221da 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 HEART ABLATION PROCEDURE ON 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'A HOLE WAS PUNCTURED IN THE RIGHT SIDE OF HER HEART THAT CAUSED INTERNAL BLEEDING.'
cause not established2955842-2013-04221Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04222da 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 LAPAROSCOPY FOR ENDOMETRIOSIS ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: HEMORRHAGED INTO LEFT OVARY AND THE PATIENT LOST ORGANS DUE TO SURGERY.
cause not established2955842-2013-04222Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04297da 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 (B)(6) 2006. 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:UMBILICAL CORD HERNIA, CONE IN UPPER INTESTINES SINCE SURGERY, PAIN, INCONTINENCE, BOWEL PROBLEMS. HAS TO HAVE STOMACH AND HERNIA SURGERY.
cause not established2955842-2013-04297Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04257da 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) 2011. EXACT PROCEDURE DATE WAS NOT PROVIDED. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BLOOD VESSELS DAMAGED DURING THE SURGERY AND DEVELOPED RAYNAUDS DISEASE. PATIENT WAS NOT ALLOWED TO HAVE CAFFEINE AND HAS TO WEAR MITTENS AROUND HER HOUSE.
cause not established2955842-2013-04257Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04189da 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 IN 2009. EXACT DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: FIVE HOUR SURGERY INSTEAD OF A 2 HOURS SURGERY, REQUIRED A BLOOD TRANSFUSION AFTER HER UTERUS WAS CUT, AFTER RECOVERY AGAIN SHE WOKE UP AND HAD A STRONG BURNING SENSATION SINCE THEN SHE HAS HAD HER GALLBLADDER REMOVED ALSO HAS FIBROMYALGIA.
cause not established2955842-2013-04189Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04275da 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) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INCONTINENCE, SEVERE PAIN, BLOOD CLOT, INFECTION, AND BLOOD TRANSFUSION REQUIRED.
cause not established2955842-2013-04275Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04196da 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 EITHER (B)(6) 2008 OR (B)(6) 2009. DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DOCTOR CUT A HOLE IN BLADDER, SURGICAL CORRECTION
cause not established2955842-2013-04196Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04271da 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 2011. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SURGERY WAS 11+ HOURS INSTEAD OF 4. KIDNEYS SHUT DOWN AND RECEIVED DIALYSIS TREATMENTS. TWO MONTHS LATER, HAD HERNIA THAT HAD TO BE REMOVED AT THE SITE OF THE INCISION
cause not established2955842-2013-04271Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04265da 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 2009. 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: INCISION HERNIA, PAIN, BOWEL INJURIES, INFECTION, INTERNAL BLEEDING, AND HAS A CATHETER IN PLACE.
cause not established2955842-2013-04265Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04194da 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 REMOVAL OF FIBROIDS FROM UTERUS PROCEDURE ON 2012. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'HOLE WAS POKED IN BOWEL, PATIENT WAS SENT HOME AN HOUR AFTER SURGERY WITHOUT KNOWING.'
cause not established2955842-2013-04194Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04235da 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 2012. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: NERVE DAMAGE TO PENIS RESULTED IN HIS INABILITY TO GET AND ERECTION, PENILE IMPLANT
cause not established2955842-2013-04235Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04241da 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 BACK SURGERY PROCEDURE ON AN UNSPECIFIED DATE. DATE OF EVENT HAS NOT BEEN PROVIDED. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: NERVE DAMAGE TO THE BLADDER.
cause not established2955842-2013-04241Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04209da 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 2004. 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'S URETHRA WAS DETACHED FROM THE BLADDER AND THE PATIENT HAD INTERNAL BLEEDING.
cause not established2955842-2013-04209Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04200da 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 2008. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'CONSTANT HEART BURN, KIDNEY STONES'.
cause not established2955842-2013-04200Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04175da 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 PROCEDURE SOMETIME IN 2007. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BOWEL LEAKAGE AND HERNIA.
cause not established2955842-2013-04175Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04239da 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 (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: BURNS TO UTERUS AND CERVIX, PAIN.
cause not established2955842-2013-04239Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04262da 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 MICRO VALVE PROCEDURE IN (B)(6) 2011. EXACT PROCEDURE DATE HAS NOT BEEN PROVIDED AT THIS TIME. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: VALVE LEAKING, LOSS OF ENERGY, DIZZY AND NAUSEA.
cause not established2955842-2013-04262Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04291da 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 (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: PELVIC PAIN, A LOT OF FATIGUE AND DEPRESSION. URETER SEVERED AND DEVELOPED SEPSIS AS A RESULT.
cause not established2955842-2013-04291Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04201da 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 DEODENAL-SWITCH BARIATRIC IN (B)(6) 2006. 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: PATIENT DID NOT HAVE ENOUGH INTESTINE (12 INSTEAD OF 18-22), COULD NOT KEEP FOOD DOWN FOR 9 MONTHS AND LOST 135LBS.
cause not established2955842-2013-04201Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04277da 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 2008. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: AFTER THE SURGERY HE WENT BACK BECAUSE OF A BLOOD CLOT. THE ER DOCS SAID THAT WAS NORMAL AFTER SURGERY. HE HAD HEMATOMAS AND INTERNAL BLEEDING. CAT SCAN REVEALED HE HAS THREE HERNIAS.
cause not established2955842-2013-04277Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04206da 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 WITH BSO 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: 'SCARRING, SCAR TISSUE COULD BE ATTACHING TO RIB(NEEDS TESTING)'.
cause not established2955842-2013-04206Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04234da 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. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INFECTION, HOSPITALIZED FOR 2 WEEKS, HEMATOMA CAUSED BY A LEAK IN A VEIN. HEMATOMA DRAINED ANALLY.
cause not established2955842-2013-04234Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEda Vinci Surgical System2955842-2013-04219da 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: HAS TROUBLE COMPLETELY EMPTYING BLADDER AND PATIENT'S RECTUM WAS RUPTURED DURING ONE OF THE FOLLOW UP SURGERIES.
cause not established2955842-2013-04219Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗