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Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 MAUDEIntuitive Surgical, Inc.da 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 ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04267da 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. 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:SURGEON CUT HOLE IN BLADDER. PATIENT HAS BEEN IN EXTREME PAIN, LEAKING URINE INTO ABDOMEN, AND BURN IN BLADDER.
cause not established2955842-2013-04267Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04247da 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. 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: SPORADIC, SEVERE ABDOMINAL PAIN, SCAR TISSUE AND PIECED OF LIGAMENTS ATTACHED TO BLADDER.
cause not established2955842-2013-04247Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04172da 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 LOWER BYPASS PROCEDURE SOMETIME IN 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: THE PATIENT CLAIMS THE SURGERY WAS DONE WRONG AND HAD TO GET LEG REMOVED BECAUSE OF AN INFECTION, DETERIORATION OF BONES AND HERNIA. NO FURTHER CLINICAL INFORMATION HAS BEEN PROVIDED.
cause not established2955842-2013-04172Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04249da 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) 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: DAMAGE CAUSED TO BLOOD VESSELS AND NERVES NEAR PENIS.
cause not established2955842-2013-04249Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04237da 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 2010. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SEVERE HEMORRHAGING REQUIRING BLOOD TRANSFUSIONS.
cause not established2955842-2013-04237Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04286da 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 LEFT KIDNEY REMOVAL IN 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DEVICE HAD NICKED HIS BOWEL AND PATIENT WAS REQUIRED TO HAVE CORRECTIVE SURGERY.
cause not established2955842-2013-04286Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04188da 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 SOMETIME IN 2012. EXACT DATE OF PROCEDURE WAS NOT PROVIDED AT THIS TIME. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PATIENT'S ABSCESS GREW ON HER INTESTINE AND IT WAS IMPACTING HER BOWELS. THE ABSCESS WAS REMOVED SOMETIME IN (B)(6) 2013.
cause not established2955842-2013-04188Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04245da 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 SOMETIME 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: INTESTINES WERE PUNCTURED AND SURGICAL CORRECTION WAS NEEDED.
cause not established2955842-2013-04245Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04287da 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 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: PATIENT DOES NOT HAVE ANY CONTROL OF BLADDER AND REQUIRED SURGICAL CORRECTION.
cause not established2955842-2013-04287Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04232da 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 HYSTEROTOMY SOMETIME IN 2009. EXACT DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DIVERTICULITIS, PAIN, CRAMPING AND PERFORATED BOWEL.
cause not established2955842-2013-04232Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04185da 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 2008. EXACT PROCEDURE DATE IS IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DESTROYED ALL NERVES, HAD NO FEELINGS, NO SEXUAL RESPONSE, AND INCONTINENCE.
cause not established2955842-2013-04185Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04226da 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: 'TWISTED BOWEL, SURGICAL CORRECTION'.
cause not established2955842-2013-04226Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04289da 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 TOTAL HYSTERECTOMY PROCEDURE IN 2009/2010. EXACT DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PUNCTURED BLADDER DURING SURGERY, CATHETERIZED FOR 6 WKS., NEVER REGAINED FULL SENSATION OF HAVING TO VOID.
cause not established2955842-2013-04289Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04250da 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 BLADDER 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: INTESTINES HERNIATED.
cause not established2955842-2013-04250Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04254da 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 REMOVAL DUE TO CANCER PROCEDURE ON (B)(6) 2010. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: NERVES IN PENIS WERE SHOCKED CAUSING HIM NOT TO HAVE AN ERECTION.
cause not established2955842-2013-04254Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04279da 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) 2012. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SUTURE FAILURE ON THE BACK-SIDE OF AN ANATOMY.
cause not established2955842-2013-04279Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04274da 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 RADICAL PROSTATECTOMY PROCEDURE IN (B)(6) 2007/2008. EXACT DATE OF PROCEDURE 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: NEUROPATHY, PAIN SITTING AND STANDING.
cause not established2955842-2013-04274Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-08FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04831da 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, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION, AND REPAIR OF UMBILICAL HERNIA ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT, AND NOTES FROM SUBSEQUENT PROCEDURES. DURING SURGERY THE RIGHT URETER WAS INADVERTENTLY CUT BY THE SURGEON, NOTED IMMEDIATELY, AND SPATULATED AND REPAIRED WITH 5-0 VICRYL SUTURE AND STENTED. IT WAS NOTED THAT THE PATIENT HAD A VERY THICKENED COVERING ON THE ANTERIOR SURFACE OF THE ABDOMEN MAKING DISSECTION DIFFICULT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE SURGEON COMPLETED A RADICAL PROSTATECTOMY WITH PLACEMENT OF TRANSPERINEAL STITCHES TO PROVED BLADDER TENSION, LYMPHADENECTOMY AND UMBILICAL HERNIA REPAIR WITHOUT ADDITIONAL COMPLICATION BEYOND THE INITIAL INADVERTENT SEVERING OF THE URETER. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2008 WITH THE RIGHT URETERAL STENT AND FOLEY CATHETER IN PLACE. ON (B)(6) 2008, THE PATIENT WAS SEEN FOR POORLY DISCHARGING FOLEY AND WAS FOUND TO HAVE A UTI. HIS FOLEY WAS REPLACED AN
cause not established2955842-2013-04831Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-06FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04022da 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 FDA VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: UNDERWENT ROBOTIC -DA VINCI- PROCTECTOMY. RECTUM WAS PERFORATED AND NOT DETECTED UNTIL SEPSIS INFECTION HAD DEVELOPED REQUIRING EXTENDED HOSPITAL STAY AND NUMEROUS SURGERIES TO CLEAN OUT THE INFECTION AND PERFORM A COLOSTOMY.
cause not established2955842-2013-04022Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-04FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04030da 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: IT WAS REPORTED THAT AFTER A DA VINCI SI SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A URETERAL INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.
cause not established2955842-2013-04030Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-04FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04052da 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 SI PROSTATECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND/OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.
cause not established2955842-2013-04052Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-04FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03982da 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. DATE OF PROCEDURE WAS NOT PROVIDED. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF A MALFUNCTION OR DEFECT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.
cause not established2955842-2013-03982Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-04FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04012da 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 SI HYSTERECTOMY. THE DATE OF THE PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES TO HER COLON AND DAMAGES THEREFROM.
cause not established2955842-2013-04012Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-03FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03980da 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. DATE OF THE PROCEDURE WAS NOT PROVIDED. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF A MALFUNCTION OR DEFECT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.
cause not established2955842-2013-03980Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-02FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04723da 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: IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2013 THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL DUE TO A BOWEL PERFORATION. IT IS UNKNOWN AT THIS TIME WHEN THE BOWEL PERFORATION WAS NOTICED. THE PATIENT WAS RECOVERING AT THE HOSPITAL AND IT IS UNKNOWN WHETHER THE PATIENT HAD ANY OTHER COMPLAINTS. THE SURGEON MENTIONED TO THE CLINICAL SALES REPRESENTATIVE (CSR) THAT THE PROBLEM WAS DUE TO THE ASSISTANT. THE CSR DOES NOT HAVE ANY FURTHER CLINICAL INFORMATION AS HE WAS NOT AT THE SITE DURING THE DA VINCI HYSTERECTOMY PROCEDURE. INTUITIVE SURGICAL INC. (ISI) ATTEMPTED TO CONTACT THE SURGEON TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT; HOWEVER, HAS BEEN UNSUCCESSFUL IN GETTING A HOLD OF THE SURGEON. BASED ON THE INFORMATION PROVIDED, THE COMPLAINT IS BEING REPORTED, SINCE THE PATIENT HAD SUFFERED A BOWEL PERFORATION AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE.
cause not established2955842-2013-04723Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-02FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04961da 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: IT WAS REPORTED THAT DURING A DA VINCI SI OVARIAN CYSTECTOMY PROCEDURE, THE PATIENT SUSTAINED A SEROSAL TEAR TO THE BOWEL THAT WAS NOTICED AFTER INSUFFLATION WAS LOST. THE INJURY WAS REPAIRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR). THE CSR WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE EVENT OCCURRED TOWARDS THE END OF THE DA VINCI SI SURGICAL PROCEDURE. AT THE TIME THE EVENT OCCURRED, PNEUMOPERITONEUM WAS LOST FROM TUBING PLACED THROUGH A LAPAROSCOPIC ASSIST PORT. DUE TO LOSS OF INSUFFLATION, THE SURGICAL STAFF LOST VISION OF THE OPERATIVE FIELD. AFTER INSUFFLATION WAS LOST, A SEROSAL TEAR WAS NOTICED ON THE PATIENT'S BOWEL. ALTHOUGH THE BOWEL WAS NOT PERFORATED, A GYN SURGEON MADE THE DECISION TO APPLY SUTURES TO THE BOWEL INJURY AS A PRECAUTION. THE CSR STATED THAT THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTS OF POST-OPERATIVE COMPLICATIONS. THE CSR STATED THAT NO MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.
cause not established2955842-2013-04961Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-10-02FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03910da 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 TOTAL BENIGN HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES. STATES PATIENT WAS MADE AWARE THAT HIS INJURIES MAY BE THE RESULT OF THE DA VINCI ON (B)(6) 2013.
cause not established2955842-2013-03910Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗
Not graded by the source2013-09-30FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04818da 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: IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE PATIENT SUSTAINED A POSSIBLE INJURY OF THE INFERIOR EPIGASTRIC ARTERY UPON ENTRY OF A TROCAR. THE CLINICAL COORDINATOR INDICATED THAT THE PATIENT HAD EXCESSIVE BLEEDING AND WAS REFERRED TO A TRAUMA SURGEON ON POST-OP DAY 2. ACCORDING TO THE CLINICAL COORDINATOR, THE ARTERIAL INJURY WAS DISCOVERED DURING EXPLORATORY SURGERY. ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE CLINICAL COORDINATOR. SHE WAS NOT PRESENT DURING THE REPORTED EVENT. SHE DID NOT KNOW WHO THE MANUFACTURER WAS OF THE TROCAR INVOLVED WITH THE EVENT. SHE ALSO DID NOT KNOW IF THE TROCAR ENTRY WAS RELATED TO A ROBOTIC PORT OR A LAPAROSCOPIC ASSIST PORT. THE CLINICAL COORDINATOR STATED THAT THE PATIENT WAS CURRENTLY STABLE AND HAS SINCE BEEN DISCHARGED HOME AFTER THE EVENT OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.
cause not established2955842-2013-04818Intuitive Surgical, Inc.da Vinci Surgical System Read the record ↗