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57 records match for Intuitive Surgical, Inc.
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Death reported2013-02-25FDA MAUDE2955842-2015-00495da 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, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY AND EXTENSIVE LYSIS OF ADHESIONS ON (B)(6) 2013 FOR POORLY DIFFERENTIATED CARCINOMA OF PROBABLE ENDOMETRIAL ORIGIN, POSTMENOPAUSAL BLEEDING, ENLARGED UTERUS AND EXTENSIVE INTRAPERITONEAL ADHESIONS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, A CYSTOSCOPY PERFORMED AT THE CONCLUSION OF THE DA VINCI SURGICAL PROCEDURE SHOWED GOOD EFFLUX OF URINE BILATERALLY FROM THE URETERAL OSTIA, AND NO VISIBLE BLADDER DEFECTS. NO OPERATIVE COMPLICATIONS WERE NOTED, AND THE ESTIMATED BLOOD LOSS WAS 150 ML. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY. THE DISCHARGE SUMMARY WAS NOT AVAILABLE FOR REVIEW. ON (B)(6) 2013, THE PATIENT PRESENTED TO AN ER WITH COMPLAINTS OF ABDOMINAL PAIN, NAUSEA, VOMITING, AND DIARRHEA. A CT-SCAN SHOWED MULTIPLE DILATED LOOPS OF FLUID FILLED BOWEL CONSISTENT
cause not established2955842-2015-00495Intuitive Surgical, Inc.Read the record ↗Death reported2013-02-16FDA MAUDE2955842-2013-00537da 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: A WALL STREET JOURNAL ARTICLE INDICATED THE FOLLOWING DETAILS RELATED TO PATIENT DEATH: 'A FOLLOW-UP STORY REFERRED TO A CASE IN WHICH A (B)(6) MAN DIED FOLLOWING ROBOTIC SURGERY LAST SUMMER AT A (B)(6) HOSPITAL. AN ATTORNEY FOR THE MAN'S FAMILY SAID THE UROLOGIST WHO OPERATED ON HIM HAD NEVER BEFORE PERFORMED THE PROCEDURE HE WAS ATTEMPTING WITH THE ROBOT, ACCORDING TO THE REPORT.'
cause not established2955842-2013-00537Intuitive Surgical, Inc.Read the record ↗Death reported2013-02-16FDA MAUDE2955842-2013-00538da 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: IN A PUBLISHED CITRON RESEARCH ARTICLE TITLED INTUITIVE SURGICAL: ANGEL WITH BROKEN WINGS, OR DEVIL IN DISGUISE? ON JANUARY 17, 2013, IT WAS STATED ON PAGE 22 IN AN EMBEDDED ARTICLE LINK (CHICAGO DAILY LAW BULLETIN - FAMILY GETS $7.5 MILLION IN DEATH AFTER SPLEEN REMOVAL) THAT A (B)(6) MAN DIED ONE MONTH AFTER A DA VINCI SURGERY TO REMOVE HIS SPLEEN IN 2007. ALLEGEDLY, THE DECEDENT UNDERWENT THE SURGERY BECAUSE HE SUFFERED FROM A DISORDER THAT PREVENTED HIS BLOOD FROM PROPERLY CLOTTING. THE DECEDENT ALLEGEDLY SUFFERED TWO HOLES IN HIS DUODENUM, AN ORGAN THAT IS 6 TO 10 INCHES FROM THE SPLEEN. FURTHERMORE, ACCORDING TO THE ARTICLE, HE BECAME SICK AND DEVELOPED SEPSIS THAT CAUSED SEVERAL ORGANS TO FAIL POST-SURGERY. IT WAS ALSO ALLEGED THAT HE SUFFERED BRAIN DAMAGE AND DIED IN (B)(6) 2007. A MEDICAL-MALPRACTICE LAWSUIT WAS FILED AGAINST FOUR DOCTORS OF THE (B)(6) -BASED HOSPITAL, WHO REPORTEDLY DENIED THE ALLEGATION THAT THE DUODENUM HOLES OCCURRED DURING THE SURGERY. INTUITIVE SURGICAL WAS NOT NAMED AS A DEFENDANT IN THIS LAWSUIT. THESE ALLEGATIONS WERE NOT PREVIOUSLY REPORTED TO INTUITIVE SURGICAL AND HAVE NOT BEEN SUBSTANTIATED. ANY FURTHER INFORMATION RECEIVED BY THE COMPANY WILL
cause not established2955842-2013-00538Intuitive Surgical, Inc.Read the record ↗Death reported2013-02-11FDA MAUDE2955842-2013-00891da 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 ALLEGED THAT THE PATIENT HAD A MULTI-PORT CHOLECYSTECTOMY ON (B)(6) 2013 THAT RESULTED IN AN INJURY TO THE BOWEL FROM THE TROCAR DURING INSERTION AT THE BEGINNING OF THE CASE. THE PATIENT COMPLAINED ABOUT PAIN TWO DAYS AFTER THE SURGERY AND RETURNED TO THE HOSPITAL. THE PATIENT WAS READMITTED, ALLEGEDLY SEPTIC AND AN EMERGENCY SURGERY WAS PERFORMED TO REPAIR THE BOWEL. THE PATIENT EXPIRED ON (B)(6) 2013.
cause not established2955842-2013-00891Intuitive Surgical, Inc.Read the record ↗Death reported2013-02-04FDA MAUDE2955842-2014-00361da 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 WHO UNDERWENT A DA VINCI NEPHRECTOMY FOR AN UNKNOWN REASON ON (B)(6) 2013. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT. NO SUPPLEMENTAL INFORMATION WAS PROVIDED. ALLEGATIONS OF PATIENT COMPLICATIONS WERE AS FOLLOWS: THE PATIENT WAS TO HAVE A PARTIAL NEPHRECTOMY, BUT BECAUSE OF COMPLICATIONS WITH THE DA VINCI HIS ENTIRE KIDNEY WAS REMOVED. HE DEVELOPED A HERNIA AND UNDERWENT ANOTHER DA VINCI ASSISTED SURGERY TO REPAIR THE HERNIA, HOWEVER THE ROBOT MALFUNCTIONED AND THE SURGERY WAS UNABLE TO BE COMPLETED. ON YET THE THIRD DAY, THE PATIENT, UNDERWENT ANOTHER DA VINCI SURGERY TO REPAIR THE HERNIA. HE SUFFERED COMPLICATIONS, BECAME SEPTIC AND EXPIRED ON (B)(6) 2013.
cause not established2955842-2014-00361Intuitive Surgical, Inc.Read the record ↗Death reported2013-01-18FDA MAUDE2955842-2018-10624da 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: THIS INITIAL MDR IS ACTUALLY BEING SUBMITTED AS A FOLLOW-UP #1 MDR REPORT FOR MFR REPORT #2955842-2014-02551 (PATIENT IDENTIFIER (B)(6)). THE COMPLAINT HANDLING SYSTEM THAT WAS USED TO SUBMIT THE INITIAL MDR IS NO LONGER AVAILABLE FOR MDR REPORT SUBMISSIONS. IN RELATION TO THE REPORTED EVENT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE PLAINTIFF¿S ATTORNEY: THE DEATH CERTIFICATE INDICATED THAT THE PATIENT¿S CAUSE OF DEATH WAS ¿SEPSIS¿ DUE TO OR AS A CONSEQUENCE OF ¿ACUTE OR CHRONIC RESPIRATORY FAILURE,¿ DUE TO OR AS A CONSEQUENCE OF ¿FALLOPIAN TUBE DAMAGE,¿ DUE TO OR AS A CONSEQUENCE OF ¿COPD AND OSA.¿ BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT DEVELOPED A PELVIC ABSCESS AND SEPTIC SHOCK, AND SUBSEQUENTLY PASSED AWAY APPROXIMATELY 6 WEEKS AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S ALLEGED PELVIC ABSCESS IS STILL UNKNOWN.
cause not established2955842-2018-10624Intuitive Surgical, Inc.Read the record ↗Death reported2013-01-18FDA MAUDE2955842-2014-02551da 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, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY FOR FIBROIDS ON (B)(6) 2013. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND SUPPLEMENTAL HOSPITAL MEDICAL RECORDS. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON NOTED THAT THERE WAS SOME DIFFICULTY PLACING TROCARS DUE TO DENSE INTRA-ABDOMINAL ADHESIONS. PERTINENT FINDINGS INCLUDED ADHESIONS OF THE BOWEL AND OMENTUM TO THE ANTERIOR ABDOMINAL WALL. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR AN ACCESSORY DURING THE OPERATION. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. AFTER THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT PRESENTED WITH THE FOLLOWING: ON (B)(6) 2013 THE PATIENT PRESENTED WITH LEAKING FLUID FROM HER VAGINA. A CYSTOSCOPY WAS PERFORMED WITH BILATERAL RETROGRADE PYELOGRAPHY. NO URINARY INJURY WAS DETECTED. A DIAGNOSTIC LAPAROSCOPY WAS INITIATED BUT THEN ABANDONED DUE TO ADHESIONS. ON (B)(6) 2013, AN EXPLORATORY LAPAROTOMY WAS THEN PERFORMED. THE BOWEL WAS FOUND TO BE DENSELY ADHERENT TO THE UPPER ANTERIOR ABDOMINAL WALL. PELVIC ABSCESSES WERE IDENTIFIED AND
cause not established2955842-2014-02551Intuitive Surgical, Inc.Read the record ↗