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Not graded by the source2020-04-13FDA MAUDE2955842-2020-10537da 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 INITIALLY REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, A FEMALE PATIENT IN HER 70'S HAD AN ULTRASONOGRAPHY PROCEDURE PERFORMED ON THE VEINS IN A LOWER LIMB, IN ADDITION TO A ECHOCARDIOGRAPHY PROCEDURE AS A RESULT OF ELEVATED LEVELS OF SOLUBLE FIBRIN AND D-DIMER IN HER POST-OPERATIVE DAY #1 BLOOD SAMPLING. DEEP VEIN THROMBOSIS (DVT) WAS FOUND AND THE PATIENT WAS ALSO SUSPECTED TO HAVE A PULMONARY EMBOLISM. AS A RESULT, THE PATIENT WAS TREATED WITH ANTICOAGULANT THERAPY AND DISCHARGED ONE WEEK POST-OPERATIVELY. THE HOSPITAL COMMENTED THAT IT IS UNKNOWN IF THE POST-OPERATIVE COMPLICATIONS WERE DIRECTLY RELATED TO THE ROBOTIC SURGERY. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON 21-MAY-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGICAL PROCEDURE WAS RECORDED ON VIDEO. HOWEVER, THE VIDEO IS NOT AVAILABLE FOR ISI TO REVIEW. NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. THERE WERE NO CONVERSIONS TO TRADITIONAL LAPAROSCOPIC OR OP
cause not established2955842-2020-10537Intuitive Surgical, Inc.Read the record ↗Not graded by the source2020-04-02FDA MAUDE2955842-2022-12185da 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 INITIALLY REPORTED THAT AT THE CONCLUSION OF A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, A BURN INJURY TO THE SKIN ON THE PATIENT'S SACRUM WAS IDENTIFIED. ALTHOUGH THE BURN SEVERITY (DEGREE) WAS UNKNOWN, IT WAS NOTED THAT THE PATIENT DID NOT RECEIVE ANY MEDICAL INTERVENTION DUE TO THE BURN INJURY. THE SURGEON/SITE DOES NOT BELIEVE AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT CAUSED OR CONTRIBUTED TO THE ALLEGED BURN INJURY. THE CUSTOMER REPORTEDLY USES SINGLE-USE DUAL-BLADE NEUTRAL PLATES (GROUNDING PADS) FOR COAGULATION, PLACING IT ON LEFT LEG FROM ABOVE. ON 07-APR-2020, ISI FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE SKIN INTEGRITY OF THE PATIENT WAS NORMAL. IT WAS NOT THIN OR FRAIL. THE PATIENT HAD NO PRE-EXISTING SKIN CONDITIONS. IT WAS CONFIRMED TO BE A BURN INJURY TO THE PATIENT'S SACRUM. IT WAS A 1ST-2ND DEGREE BURN. THE BURN INJURY WAS REPORTED TO BE "10X20SM, RECTANGULAR, RED, WITH BLISTERS. THE PATIENT RECEIVED LOCAL SKIN TREATMENT AND WOUND DRESSING. THE SURGEON BELIEVED THAT THE BURN INJURY WAS DUE TO ¿NOT PROPER ISOLATION OF THE OPERATING TABLE.¿ THE GROUNDING PAD WAS CORRECTLY PLACED ON THE PATIENT'S LEFT LEG. IT WAS INSPECTED BEFORE
cause not established2955842-2022-12185Intuitive Surgical, Inc.Read the record ↗Not graded by the source2020-04-01FDA MAUDE2955842-2020-10626da 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2020-10626Intuitive Surgical, Inc.Read the record ↗Not graded by the source2020-03-19FDA MAUDE2955842-2020-10526da 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2020-10526Intuitive Surgical, Inc.Read the record ↗Not graded by the source2020-03-16FDA MAUDE2955842-2020-10622da 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2020-10622Intuitive Surgical, Inc.Read the record ↗Not graded by the source2020-01-17FDA MAUDE2955842-2020-10687da 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: REFER TO FOR FOLLOW-UP INFORMATION.
cause not established2955842-2020-10687Intuitive Surgical, Inc.Read the record ↗Not graded by the source2019-12-20FDA MAUDE2955842-2022-12486da 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 UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, DISSECTION OF THE VAGINAL STUMP WAS PERFORMED, AND TISSUE WAS DAMAGED. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE STUMP OF THE VAGINA WAS INJURED DURING THE PROCEDURE. THE CAUSE OF THE INJURY WAS ATTRIBUTED TO THE SURGEON¿S MISJUDGMENT. THE SURGEON CONFIRMED THAT ANOTHER STITCH SHOULD HAVE BEEN PLACED. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS REQUIRED TO REPAIR THE VAGINAL STUMP. ADDITIONALLY, THE SURGEON STATED THAT THE EVENT DID NOT OCCUR AS A RESULT OF THE DA VINCI SURGICAL SYSTEM MALFUNCTION. THE SURGERY WAS COMPLETED AS PLANNED AND THE PATIENT HAS PROGRESSED WELL WITHOUT ANY PROBLEMS.
cause not established2955842-2022-12486Intuitive Surgical, Inc.Read the record ↗Not graded by the source2019-12-18FDA MAUDE2955842-2020-11298da 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 VIA A GENERAL PHYSICIAN INQUIRY THAT AFTER A COMPLETED DA VINCI-ASSISTED GYNECOLOGY PROCEDURE, POSSIBLY ON (B)(6) 2019, PATIENT INJURY WAS REPORTED. THE PATIENT RETURNED TO THE HOSPITAL SIX TO SEVEN DAYS POST DA VINCI PROCEDURE, POSSIBLY ON (B)(6)2019, FOR WHAT WAS DESCRIBED AS ¿REPAIR¿ AS THERE WAS AN OBSERVED ¿TROCAR INJURY¿ AND ¿BOWEL NECROSIS¿. FURTHER DETAIL WAS UNKNOWN. THE PATIENT¿S CURRENT STATUS IS ALSO UNKNOWN.
cause not established2955842-2020-11298Intuitive Surgical, Inc.Read the record ↗Not graded by the source2019-12-05FDA MAUDE2955842-2020-10589da 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2020-10589Intuitive Surgical, Inc.Read the record ↗Not graded by the source2019-11-13FDA MAUDE2955842-2020-10599da 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2020-10599Intuitive Surgical, Inc.Read the record ↗Not graded by the source2019-04-08FDA MAUDE2955842-2021-11644da 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 WHO UNDERWENT A "PARTIAL NEPHROTIC ROBOTIC LAPAROSCOPIC PROCEDURE" ON (B)(6)2019 WHO WAS READMITTED TO THE HOSPITAL "FOUR DAYS AFTER HER SURGERY" ON (B)(6) 2021 EXHIBITING POST-OPERATIVE SYMPTOMS OF ¿REGURGITATED APPROXIMATE 30 TIMES DURING THE PREVIOUS NINE HOURS"; VOMITING "BLACK COFFEE GROUND MATERIAL THAT SMELLED OF FECES." A RE-OPERATION WAS PERFORMED TO REPAIR AN "8MM HOLE" THAT HAD BEEN ¿LEFT BY THE ARM OF THE TROCHAR" CAUSING THE PATIENT¿S BOWEL TO BECOME "HERNIATED AND STRANGULATED." THE PATIENT WAS REPORTED AS STABLE AND THE PATIENT WAS DISCHARGED. IT WAS ALSO ALLEGED THAT A "BROKEN MACHINE" WAS NOT "ADEQUATELY REPAIRED" PRIOR TO THE INITIAL PROCEDURE ON (B)(6) 2019. IT WAS ALSO ALLEGED THAT DURING THE INITIAL PROCEDURE ON (B)(6) 2019, THERE WAS A "NEED TO CONVERT TO AN OPEN PROCEDURE," THERE WERE "ADDITIONAL OR LARGER INCISIONS," THAT THERE WAS ¿EQUIPMENT FAILURE," AND THERE WERE "UNCONTROLLED ELECTRICAL CURRENTS" WITH "PARTS OF THE ROBOT BEING LEFT BEHIND," AND THERE WERE "TISSUE BURNS" DUE TO "THE SURGEON NOT BEING IN TOTAL CONTROL OF THE ROBOT." THE FOLLOWING ADDITIONAL
cause not established2955842-2021-11644Intuitive Surgical, Inc.Read the record ↗Not graded by the source2018-11-29FDA MAUDE2955842-2023-12187da 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 28-MAR-2023, INTUITIVE SURGICAL BECAME AWARE OF A JOURNAL OF BREAST CANCER ARTICLE TITLED, ¿DEVELOPMENT OF ROBOTIC MASTECTOMY USING A SINGLE-PORT SURGICAL ROBOT SYSTEM¿ (PARK, H.S., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, IT WAS MENTIONED AFTER A BILATERAL DA-VINCI ASSISTED MASTECTOMY PERFORMED ON (B)(6) 2018 ON A PATIENT WITH DUCTAL CARCINOMA IN SITU (DCIS), THERE WAS A MINOR SKIN BURN FOUND ON THE RIGHT BREAST. THERE WAS NO MENTION OF MEDICAL TREATMENT TO ADDRESS THE MINOR SKIN BURN IN THE ARTICLE. THERE WERE NO OTHER IMMEDIATE POSTOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY 15 AND DRAIN WAS REMOVED ON DAY 24. PATIENT RE-VISITED THE CLINIC ON DAY 55 BECAUSE OF REDNESS AND HEATING SENSATION OF THE RIGHT BREAST. ANTIBIOTICS AND CONSERVATIVE TREATMENT INCLUDING DRESSING AND RE-INSERTION OF THE DRAIN WERE APPLIED. HER SYMPTOMS SUBSIDED AFTER 1 DAY OF TREATMENT AND NO MAJOR SURGICAL INTERVENTION WAS NEEDED. THERE WAS NO MENTION OF ANY MALFUNCTIONS OF ANY DV SYSTEMS, INSTRUMENTS OR ACCESSORIES. FENESTRATED BIPOLAR FOCEPS (FBF) INSTRUMENT, MARLAND FORCEPS INSTRUMENT AND MONOPOLAR CURVED SCISSORS (MCS) WERE INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR(US
cause not established2955842-2023-12187Intuitive Surgical, Inc.Read the record ↗Not graded by the source2018-05-28FDA MAUDE2955842-2022-12042da 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: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN INNOVATIONS JOURNAL ARTICLE TITLED, "EARLY CLINICAL EXPERIENCES OF ROBOTIC ASSISTED AORTIC VALVE REPLACEMENT FOR AORTIC VALVE STENOSIS WITH SUTURELESS AORTIC VALVE¿ (NAGAOKA, E. ET. AL. 2020). IN THIS ARTICLE, STUDY DATA WAS RETROSPECTIVELY COLLECTED FROM 2 PATIENTS WHO UNDERWENT DA VINCI-ASSISTED AORTIC VALVE REPLACEMENT (AVR) IN A SINGLE INSTITUTION BETWEEN MAY AND JUNE 2018. THERE WERE NO MAJOR COMPLICATIONS REPORTED AND NO CONVERSIONS TO STERNOTOMY. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: "ONE PATIENT HAD FLUID OVERLOAD POSTOPERATIVELY DUE TO VASODILATATION AND REQUIRED AGGRESSIVE DIURESIS. OTHERWISE, POSTOPERATIVE CONVALESCENCE WAS UNCOMPLICATED. THEY WERE DISCHARGED HOME AT DAYS 4 AND 10 AFTER OPERATION, DUE TO POSTOPERATIVE ATRIAL FIBRILLATION RESPECTIVELY (TABLE 3)." ISI FOLLOWED UP WITH THE AUTHOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE ARTICLE: "THE POST-OPERATIVE OUTCOME WAS UNRELATED TO THE FUNCTION OF THE DA VINCI SYSTEM." HE FURTHER INDICATED THAT "THERE ARE NO SUCH ALLEGATIONS" THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE INVOLVING THE
cause not established2955842-2022-12042Intuitive Surgical, Inc.Read the record ↗Not graded by the source2017-12-28FDA MAUDE2955842-2020-11212da 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2020-11212Intuitive Surgical, Inc.Read the record ↗Not graded by the source2014-12-31Press records
In addition, as further described in Note 7 to the Consolidated Financial Statements included in Part II, Item 8, we are currently named as a defendant in approximately 102 individual product liability lawsuits and a multi-plaintiff product liability lawsuit filed on behalf of 20 patients who underwent da Vinci Surgery.
cause not establishedIntuitive Surgical, Inc.Read the record ↗Not graded by the source2012-01-01FDA MAUDE2955842-2022-12342da 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 26-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE.¿ WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: CASE #2 INVOLVED A 66-YEAR OLD FEMALE PATIENT WITH STAGE 1A CANCER WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF AORTA.¿ ¿IN CASE 2, THE AORTA WAS PARTIALLY STAPLED UPON DIVIDING THE INTERLOBAR FISSURE BETWEEN THE APICO-POSTERIOR SEGMENT OF THE LEFT UPPER LOBE AND THE APICAL SEGMENT OF THE LEFT LOWER LOBE, WHICH WAS REPAIRED BY END-TO-END ANASTOMOSIS UNDER BYPASSING WITH EXTRACORPOREAL MEMBRANOUS OXYGENATION. IN BOTH CASES CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED.¿ THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. FURTHERMORE, IT WAS NOTED IN REFERENCE TO CASE #2 (AND CASE #1), "IN BOTH CASES, CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED." ADDITIONALLY, THE ARTICLE STATES THE FOLLOWING: "WE EXPERIENCED TWO C
cause not established2955842-2022-12342Intuitive Surgical, Inc.Read the record ↗Not graded by the source2011-01-01FDA MAUDE2955842-2022-12290da 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 26-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE.¿ WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: CASE #1 INVOLVED A 48-YEAR OLD FEMALE PATIENT WITH STAGE 1B CANCER WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF PA¿ (PULMONARY ARTERY).¿IN CASE 1, THE CAUSE OF CONVERSION WAS UNCONTROLLABLE BLEEDING FROM AN INJURY TO THE LINGUAL SEGMENTAL PULMONARY ARTERY DURING STAPLING OF THE INCOMPLETE INTERLOBAR FISSURE.¿ FURTHERMORE, IT WAS NOTED IN REFERENCE TO CASE #1 (AND CASE #2) "IN BOTH CASES, CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED." ADDITIONALLY, THE ARTICLE STATES THE FOLLOWING: "WE EXPERIENCED TWO CONVERSIONS IN STAPLING THE FISSURE OF THE LEFT UPPER LOBE. BOTH CONVERSIONS WERE CAUSED BY FAILURE TO CONFIRM THAT THE TIP OF THE STAPLER WAS FREE FROM THE ADJACENT STRUCTURES. THIS IS PARTLY ATTRIBUTABLE TO THE SPECIFIC CHARACTERISTICS OF THE 30 DEGREE ANGLED SCOPE: IT IS DIFFICULT TO OBSERVE LATERALLY U
cause not established2955842-2022-12290Intuitive Surgical, Inc.Read the record ↗Not graded by the source2010-04-21FDA MAUDE1669451da 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: UROLOGIST CALLED TO REPORT PROBLEMS WITH ROBOTIC EQUIPMENT. THE UROLOGIST HAD TO CONVERT THE ROBOTIC PROSTATECTOMY CASE TO OPEN WHEN THE SYSTEM STOPPED WORKING. THE NEXT WEEK, THE SURGEON HAD TWO ROBOTIC PROSTATECTOMIES. DURING THE FIRST CASE THERE WERE 10 ALARMS WITH THE ERROR #20013, THAT SAID PRESS FAULT OVERRIDE BUTTON. DESPITE THIS PROBLEM THE FIRST CASE WENT AS PLANNED WITHOUT ANY OTHER ISSUES. DURING THE SECOND CASE THE SAME PROBLEM WITH THE FAULT ALARM OCCURRED THREE TIMES; ON THE THIRD TIME THE FAULT DID NOT OVERRIDE. THE MANUFACTURER WAS CONTACTED USING THE DAVINCI HELP NUMBER. WE WERE INSTRUCTED TO UNDOCK THE ROBOT COMPLETELY AND POWER DOWN. I WAS INSTRUCTED TO CHECK SOME CONNECTIONS ON THE CONSOLE, WHICH WERE FINE. THEN WE TURNED ON THE ROBOT AND STARTED AGAIN. WE HAD ANOTHER FAULT THAT WE COULD NOT OVERRIDE, SO I CALLED THE COMPANY AGAIN, HAD THE SURGEON PRESS THE EMERGENCY STOP BUTTON AND THEN FAULT OVERRIDE. THIS WAS TO RELEASE THE INSTRUMENTS' GRASPS ON THE TISSUE. AT THAT TIME THERE WAS A BLEEDER THAT HADN'T FULLY GOTTEN UNDER CONTROL BECAUSE THE ROBOT WAS FROZEN. THERE WERE THREE MORE FAULTS BEFORE WE HAD ANOTHER IRRECOVERABLE FAULT. THE SURGEON DECIDED TO COMPLET
cause not established1669451Intuitive Surgical, Inc.Read the record ↗Not graded by the source2010-03-26FDA MAUDE2955842-2010-00122da 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 POST A DA VINCI SI THYROIDECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS DUE TO RADIAL NERVE DAMAGE.
cause not established2955842-2010-00122Intuitive Surgical, Inc.Read the record ↗Not graded by the source2010-03-18FDA MAUDE2955842-2010-00156da 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 POST A DA VINCI MYOMECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS IN HER HANDS AND FINGERS AND SHARP PAIN AND TINGLING IN HER LEGS. PER THE SURGEON THAT PERFORMED THE OPERATION, THE MYOMECTOMY PROCEDURE TOOK LONGER THAN ANTICIPATED, APPROXIMATELY 5 HOURS, WITH THE PATIENT IN THE TRENDELENBURG POSITION. PER THE OPERATIVE REPORT THE PATIENT TOLERATED THE ENTIRE PROCEDURE WELL WITH GOOD HEMOSTASIS AND MINIMAL BLOOD LOSS.
cause not established2955842-2010-00156Intuitive Surgical, Inc.Read the record ↗Not graded by the source2010-03-10FDA MAUDE2955842-2010-00140da 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 APPROXIMATELY 45 MINUTES INTO A DA VINCI PROSTATECTOMY PROCEDURE, WHILE THE SURGEON WAS PERFORMING A DISSECTION, THE MONOPOLAR FOOT PETAL WAS PRESSED, HOWEVER, THE BIPOLAR ENERGY BECAME ACTIVATED. THE BIPOLAR INSTRUMENT WAS HOLDING TISSUE AND CREATED A SUPERFICIAL LACERATION TYPE BURN TO THE PATIENT'S BOWEL. A GENERAL SURGEON REVIEWED THE INJURY AND DETERMINED THAT THE BURN WAS NOT THROUGH AND THROUGH AND DID NOT REQUIRE REPAIR, HOWEVER, THE SURGEON PLACED ONE SUTURE IN THE PATIENT'S BOWEL AS A PRECAUTION. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT AND NO FURTHER INSTANCES OF THE EVENT WAS REPORTED.
cause not established2955842-2010-00140Intuitive Surgical, Inc.Read the record ↗Not graded by the source2010-02-05FDA MAUDE2955842-2010-00084da 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 PHYSICIAN AT THE SURGEON SIDE CONSOLE INTERMITTENTLY FELT A SHOCK IN HIS FINGERTIPS FROM THE RIGHT MASTER TOOL MANIPULATOR (MTMR). THE SURGEON SWITCHED TO THE SITE'S SECOND SURGEON SIDE CONSOLE TO COMPLETE THE PLANNED PROCEDURE AND NO FURTHER OCCURRENCES OF SHOCK WERE REPORTED. NO HARM TO THE PHYSICIAN OR PATIENT WAS REPORTED.
cause not established2955842-2010-00084Intuitive Surgical, Inc.Read the record ↗Not graded by the source2010-01-27FDA MAUDE2955842-2010-00060da 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 APPROXIMATELY 2.5 HOURS INTO A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON BEGAN TO INITIATE A TOOL CHANGE TO SWITCH INSTRUMENTS. AT THIS TIME THE NURSE ASSISTANT WHO WAS RETRACTING THE PATIENT'S UTERUS, DROPPED THE UTERUS CAUSING THE SURGEON TO LOSE SITE OF THE TENNACULUM FORCEPS INSTRUMENT IN USE. THE PATIENT SIDE MANIPULATOR (PSM) ARM THAT THE TENNACULUM FORCEPS INSTRUMENT WAS INSTALLED ON BECAME UNRESPONSIVE. THE ISI REPRESENTATIVE ONSITE HAD THE SURIGCAL STAFF EMERGENCY STOP THE SYSTEM AND PERFORM A FAULT OVER-RIDE, HOWEVER, THE PSM CONTINUED TO BE UNRESPONSIVE. THE PATIENT'S UTERUS WAS MOVED, AND THE SURGICAL STAFF FOUND THAT THE TENNACULUM FORCEPS INSTRUMENT WAS CLOSED ON THE PATIENT'S RECTUM AND THEY WERE UNABLE TO RELEASE THE INSTRUMENT. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE INSTRUMENT WAS RELEASED AND REMOVED FROM THE PSM. A GENERAL SURGEON WAS REQUESTED TO ATTEND THE PROCEDURE AND ALTHOUGH THERE WERE NO VISIBLE HOLES, TEARS, OR PINCHES IN THE PATIENT'S RECTUM, HE PLACED A FEW SUTURES AS A PRECAUTION. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH OUT ANY FURTHER PATIENT HARM, INJURY OR ADVERSE OUTCOME REPORTED.
cause not established2955842-2010-00060Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-12-30FDA MAUDE2955842-2010-00031da 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 WHILE MOBILIZING THE LEFT INTERNAL MAMMARY ARTERY DURING A DA VINCI S CABG PROCEDURE, THE MICRO BIPOLAR FORCEPS (MBF) INSTRUMENT JUMPED FORWARD AND PUNCTURED THE PATIENT'S ARTERY. THE DAMAGED SECTION OF THE ARTERY WAS TRANSECTED AND THE HEALTHY PORTION OF THE ARTERY WAS USED TO COMPLETE THE BYPASS. IT WAS ALSO REPORTED THAT THROUGHOUT THE CASE, PNEUMO WAS ESTABLISHED AND LOST SEVERAL TIMES. THE ISI REPRESENTATIVE PRESENT DURING THE PROCEDURE INDICATED THAT PRIOR TO THE MBF INSTRUMENT JUMP, THE SURGEON NOTED THAT WHEN THE MASTER TOOL MANIPULATOR WAS MOVED, THE INSTRUMENT FELT STUCK AND THEN MOVED. IT IS BELIEVED THAT THE SURGEON CAUGHT THE MBF INSTRUMENT IN THE PATIENT'S RIB. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES OR PATIENT HARM.
cause not established2955842-2010-00031Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-12-18FDA MAUDE2955842-2009-00410da 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 BY THE PT THAT SHE RECENTLY HAD A DA VINCI HYSTERECTOMY PROCEDURE AND WAS UNDER ANESTHESIA FOR 8 HOURS INSTEAD OF THE EXPECTED 4 HOURS DUE TO HER BEING SEVERELY OVERWEIGHT. SHE STATED THAT SHE WOKE UP AND WAS UNABLE TO MOVE EITHER OF HER ARMS, HOWEVER, AFTER TIME, SHE WAS ABLE TO GET FULL USE OF HER LEFT ARM. SHE STATED HER RIGHT ARM IS STILL IN A LOT OF PAIN.
cause not established2955842-2009-00410Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-12-03FDA MAUDE2955842-2010-00007da 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 THE DAY FOLLOWING A SUCCESSFUL DA VINCI SI PROSTATECTOMY PROCEDURE, THE PT DEVELOPED COMPARTMENT SYNDROME IN THEIR RIGHT ARM. A SURGICAL PROCEDURE WAS PERFORMED TO RELIEVE PRESSURE TO THE PT'S AFFECTED AREA. NO ADD'L PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.
cause not established2955842-2010-00007Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-10-16FDA MAUDE2955842-2009-00346da 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 SEPTEMBER 18, 2009, A REUTERS ARTICLE TITLED "MEDICAL SOCIETIES PUSH STANDARDS FOR ROBOTIC SURGERY" WAS PUBLISHED. THE ARTICLE INCLUDES QUOTES FROM DR. KEVIN ZORN AND MENTIONS HIS RECOUNT OF A CASE WHERE A PATIENT DIED POST A DA VINCI PROSTATECTOMY PROCEDURE: "HE RECOUNTED ONE CASE OF A SURGEON WHO WAS USING THE SYSTEM FOR THE FOURTH TIME. AFTER EIGHT HOURS OF SURGERY, THE PROCTOR -- AN EXPERIENCED SURGEON WHO SUPERVISES THE OPERATION -- TOLD THE SURGEON THAT PROGRESS WAS TOO SLOW. HE RECOMMENDED THE SURGEON SWITCH TO CONVENTIONAL SURGERY, WHERE AN INCISION IS MADE FROM THE NAVEL TO THE PUBIC BONE TO ACCESS THE PROSTATE. AFTER THE PROCTOR LEFT THE OPERATING ROOM, THE SURGEON CONTINUED USING THE ROBOT. THE PATIENT LATER DIED FROM COMPLICATIONS." ON SEPTEMBER 29, 2009, UPON FOLLOWING UP, IT WAS DISCOVERED THAT ANOTHER DR WAS THE PROCTOR.
cause not established2955842-2009-00346Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-10-07FDA MAUDE2955842-2009-00363da 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 TOWARD THE END OF A DA VINCI S SACRALCOPOPEXY PROCEDURE, THE CONSOLE SURGEON EXPERIENCED USER MESSAGE "LIGHTEN GRIP". THE CONSOLE SURGEON ATTEMPTED TO TROUBLESHOOT THE SYSTEM ERROR BY RELEASING THE GRIPS ON THE MASTER TOOL MANIPULATORS (MTM); HOWEVER, THE SYSTEM ERROR PERSISTED. THE CONSOLE SURGEON THEN PLACED THEIR HEAD BACK INTO THE HIGH RESOLUTION STEREO VIEWER (HSRV) LOCATED ON THE SURGEON'S CONSOLE AND ACCIDENTLY CLUTCHED AND CHANGED CONTROL OF THE PATIENT SIDE MANIPULATOR (PSM) FROM PSM 2 TO PSM 3. THE SURGEON WAS UNCLEAR WHY THE INSTRUMENT ON THE PSM 2 WAS NOT MOVING WHEN SHE NOTICED THAT SHE HAD ACCIDENTLY CLUTCHED AND GAINED CONTROL OF THE INSTRUMENT IN PSM 3. AT THIS POINT, THE SURGEON HAD ALREADY MOVED PSM 3 WITH INSTRUMENT DOWN CAUSING THE INSTRUMENT TO MAKE CONTACT AND INJURING THE PATIENT'S SACRAL. THE CASE WAS CONVERTED TO A TRADITIONAL OPEN PROCEDURE AND THE PATIENT'S INJURY WAS REPAIRED AND THE PROCEDURE WAS COMPLETED. AS OF 2009, THE PATIENT WAS REPORTED AS DOING WELL WITH NO FURTHER ISSUES.
cause not established2955842-2009-00363Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-09-18FDA MAUDE2955842-2009-00347da 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 4 DAYS POST OP, A DA VINCI SI HYSTERECTOMY PROCEDURE, A 5MM PERFORATION OF THE PT'S BOWEL WAS OBSERVED DURING A LAPAROSCOPIC COLOSTOMY PROCEDURE. IN 2009, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFO: PRE-OPERATIVELY, THE PT EXPERIENCED COMPLICATIONS OF SEVERE BOWEL IMPACTION (HARD STOOL) THROUGHOUT THE ENTIRE LARGE INTESTINE DUE TO DIVERTICULOSIS. THE PT'S BOWEL WAS INFUSED WITH AN ENEMA AND CONTRAST ALL THE WAY TO THE CECUM TO AID IN THE MOVEMENT OF THE PT'S BOWEL. IN ADDITION, THE PT HAD A COLOSTOMY TUBE THAT PRESENTED LEAKAGE THUS CAUSING THE PT TO DEVELOP AN INFECTION. IT IS UNK HOW DAMAGE TO THE PT'S BOWEL OCCURRED; HOWEVER, THE PERFORATION MAY HAVE BEEN INTRODUCED DURING THE ENEMA AND CONTRAST PROCEDURE. THE PT REMAINS HOSPITALIZED AS OF THE SAME DAY. IN ADDITION, THE INFECTION IS UNDER CONTROL AND THE PT IS REPORTED TO BE DOING WELL.
cause not established2955842-2009-00347Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-09-16FDA MAUDE2955842-2010-00121da 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 POST A DA VINCI S THYROIDECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS, DUE TO RADIAL NERVE DAMAGE.
cause not established2955842-2010-00121Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-09-15FDA MAUDE2955842-2009-00337da 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 S HYSTERECTOMY PROCEDURE, THE SURGEON ACTIVATED THAT MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WHILE IT WAS OUT OF THEIR FIELD OF VIEW AND ACCIDENTLY LACERATED THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE AND THE DAMAGE TO THE PATIENT'S ARTERY WAS REPAIRED USING A PRIMARY CLOSURE TECHNIQUE. THE PATIENT WAS REPORTED TO BE DOING WELL AND HAS NOT EXPERIENCED ANY POST OPERATIVE COMPLICATIONS.
cause not established2955842-2009-00337Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-08-17FDA MAUDE2955842-2009-00221da 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: IN 2008, IT WAS REPORTED THAT AFTER A SUCCESSFUL DA VINCI S MITRA VALVE REPAIR PROCEDURE, THE PT DEVELOPED COMPLICATIONS RELATED TO A HEPARIN INDUCED THROMBOCYTOPENIA. AS A RESULT, THE PT'S LEG WAS AMPUTATED. NO ADDITIONAL INFO HAS BEEN PROVIDED BY THIS SITE DESPITE ATTEMPTS.
cause not established2955842-2009-00221Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-08-04FDA MAUDEMW5012442da 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: DURING A ROBOTIC DAVINCI CASE THE INSTRUMENT ARM GRASPER BROKE INSIDE PT, BUT STAYING INTACT. AFTER COMPLETION OF CASE A CUTDOWN WAS PERFORMED AT THE INCISION SITE ALLOWING REMOVAL OF INSTRUMENT. OP REPORT: INSTRUMENT THROUGH 3RD DAVINCI ARM SNAPPED AT LEVEL OF PORT AND GIVEN ANGULATION; WAS DIFFICULT TO REMOVE THROUGH POA. AT THE END OF THE CASE, ARM WAS MANIPULATED AND INSTRUMENT WAS PULLED ALONG WITH ARM AFTER EXTENDING INCISION BY 2-3CM. PELVIC CAVITY WAS IRRIGATED, FRAGMENTS FROM INSTRUMENT SHEATH WERE REMOVED.
cause not establishedMW5012442Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-07-13FDA MAUDE2955842-2009-00263da 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 THREE DAYS AFTER A SUCCESSFUL DA VINCI S HYSTERECTOMY PROCEDURE, THE PT WAS RE-ADMITTED TO THE HOSP WITH A TEMPERATURE AND PERITONITIS SYMPTOMS. TWO DAYS AFTER BEING ADMITTED, A DIAGNOSTIC LAPAROSCOPY PROCEDURE WAS PERFORMED, RESULTING IN THE DISCOVERY OF EIGHT SITES ON THE PT'S SIGMOID COLON NEEDING OVER SEWING. SIX OF THE EIGHT SITES WERE IDENTIFIED AS THERMAL BURNS. NO ADDITIONAL PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.
cause not established2955842-2009-00263Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-06-17FDA MAUDE2955842-2009-00196da 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 POST A DA VINCI HYSTERECTOMY PROCEDURE, THE PT DEVELOPED RIGHT SHOULDER PARALYSIS. REPORTEDLY, PRIOR TO STARTING THE PLANNED SURGICAL PROCEDURE, THE SITE EXPERIENCED DIFFICULTIES PLACING THE PT IN THE TRENDELENBURG POSITION AND THE PT EXPERIENCED LABORED BREATHING.
cause not established2955842-2009-00196Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-04-10FDA MAUDE2955842-2009-00157da 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 POST A DA VINCI S SACROCOLPOPEXY PROCEDURE, THE PT DEVELOPED DEEP VIN THROMBOSIS (DVT). NO ADDITIONAL PT HARM OR ADVERSE OUTCOME WAS REPORTED.
cause not established2955842-2009-00157Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-02-24FDA MAUDE2955842-2009-00118da 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 POST A DA VINCI S PROSTATECTOMY PROCEDURE, THE PATIENT DEVELOPED BILATERAL LEG NERVE PALSY. NO ADDITIONAL PATIENT HARM OR ADVERSE OUTCOME WAS REPORTED.
cause not established2955842-2009-00118Intuitive Surgical, Inc.Read the record ↗Not graded by the source2009-02-12FDA MAUDE2955842-2009-00106da 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 SURGICAL PROCEDURE, THE ENDOSCOPE TIP BECAME VERY HOT AND BURNT THE PATIENT'S BOWEL. SURGICAL INTERVENTION WAS NOT REQUIRED, AND THE PLANNED PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES.
cause not established2955842-2009-00106Intuitive Surgical, Inc.Read the record ↗Not graded by the source2008-11-26FDA MAUDE2955842-2008-01443da 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: AFTER A DA VINCI HYSTERECTOMY PROCEDURE, DURING THE CYSTOSCOPY, IT WAS FOUND THAT THE PATIENT'S URETER HAD BEEN DAMAGED. THE URETER WAS REPAIRED VIA A URETERONEOCYSTOTOMY PROCEDURE, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. NO ADDITIONAL PATIENT HARM OR ADVERSE OUTCOME WAS REPORTED.
cause not established2955842-2008-01443Intuitive Surgical, Inc.Read the record ↗Not graded by the source2008-11-19FDA MAUDE2955842-2008-01448da 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 8 DAYS AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, THE PT UNDERWENT AN EXPLORATORY LAPAROSCOPY PROCEDURE WHERE A BOWEL PERFORATION WAS DISCOVERED. THE PERFORATION WAS REPAIRED, HOWEVER, THE PT BECAME SEPTIC DUE TO A BILIOUS FLUID LEAKAGE. THE PT WAS IN CRITICAL CARE FOR 2 WEEKS AND WAS THEN TRANSFERRED TO LONG TERM CARE. NO ADD'L PT HARM OR ADVERSE OUTCOME WAS REPORTED.
cause not established2955842-2008-01448Intuitive Surgical, Inc.Read the record ↗Not graded by the source2008-06-16FDA MAUDE2955842-2008-01144da 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 S BEATING HEART DOUBLE VESSEL CORONARY ARTERY BYPASS GRAFT PROCEDURE AT THE HOSPITAL, THERE WAS AN UNEXPLAINED MOVEMENT ON THE SYSTEM ARM WHICH HAD THE ENDOWRIST STABILIZER INSTRUMENT ATTACHED TO IT. THE UNEXPECTED MOVEMENT CAUSED THE FEET AT THE DISTAL END OF THE ENDOWRIST STABILIZER INSTRUMENT TO TIP DOWNWARD RESULTING IN DAMAGE TO THE MYOCARDIUM OF THE PATIENT'S LEFT VENTRICLE. THE SURGICAL TEAM IMMEDIATELY CONVERTED TO AN OPEN STERNOTOMY TO SUCCESSFULLY REPAIR THE DAMAGED VENTRICLE WITH A SINGLE MEDTRONIC U-CLIP S50. THE PATIENT WAS REPORTED AS RECOVERING WELL WITH NO POST-OPERATIVE COMPLICATIONS.
cause not established2955842-2008-01144Intuitive Surgical, Inc.Read the record ↗Not graded by the source2008-05-21FDA MAUDE2955842-2008-01076da 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 TOWARDS THE END OF A DA VINCI S GYNECOLOGIC DIAGNOSTIC LAPAROSCOPY PROCEDURE, THE ASSISTANT SURGEON PLACED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INSIDE OF THE PT'S BODY AND WAS MOVING THE INSTRUMENT OUTSIDE OF THE FIELD OF VIEW. THE CONSOLE SURGEON TOOK CONTROL OF THE INSTRUMENT WITHOUT HAVING A VISUAL OF WHERE THE INSTRUMENT WAS LOCATED AND ACTIVATED THE INSTRUMENT TIP, WHICH CREATED A TRANSECTION CUT TO THE PT'S RIGHT INTERNAL ILIAC ARTERY AND RIGHT URETER. THE PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES AND A VASCULAR SURGEON AND UROLOGIST WERE CALLED IN TO REPAIR THE PT'S RIGHT INTERNAL ILIAC ARTERY AND STENT THE URETER. A BLOOD TRANSFUSION WAS REQUIRED DURING THE REPAIR SURGERY. IT WAS REPORTED THAT THE PT IS RECOVERING AS PLANNED POST-OPERATIVE DAY 27.
cause not established2955842-2008-01076Intuitive Surgical, Inc.Read the record ↗Not graded by the source2008-04-29FDA MAUDE2955842-2008-01195da 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 7/11/08, ISI RECEIVED MEDWATCH REPORT, WHICH INDICATES THAT AN ADVERSE EVENT OCCURRED IN '08, DURING THE USE OF THE DA VINCI S SURGICAL SYSTEM AND A GYNECARE X-TRACT TISSUE MORCELLATOR IN A SURGICAL PROCEDURE. THE REPORT WAS SUBMITTED TO THE FDA BY THE PT, HOWEVER, A DESCRIPTION OF THE EVENT WAS NOT PROVIDED.
cause not established2955842-2008-01195Intuitive Surgical, Inc.Read the record ↗Not graded by the source2008-04-01FDA MAUDE2955842-2008-01176da 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: IN 2008, IT WAS REPORTED THAT THE SITE EXPERIENCED A SYSTEM FAULT WHILE SETTING UP FOR A DA VINCI S PROSTATECTOMY SURGICAL PROCEDURE. NO PT ISSUES WERE REPORTED AT THAT TIME. ON 7/3/08, ADDITIONAL INFO WAS RECEIVED FROM THE ATTENDING SURGEON WHO INDICATED THAT CONTINUOUS SYSTEM FAULTS OCCURRED AFTER THE PT PORTS WERE PLACED, RESULTING IN A 1 HOUR DELAY. DURING THE DELAY, THE PT'S ABDOMEN BECAME DEFLATED AND THE PT BUCKED VERTICALLY. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER VIA TELEPHONE, THE SYSTEM FAULTS WERE RESOLVED BY CLEANING THE FIBEROPTIC CABLE AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THE PT RETURNED TO THE OPERATING ROOM THREE DAYS AFTER THE PROCEDURE WAS PERFORMED WITH THE SYSTEM AND A SMALL BOWEL LACERATION WAS DISCOVERED AND REPAIRED. IT IS BELIEVED THAT THE SMALL BOWEL LACERATION WAS CAUSED AT SOME POINT IN THE PROCEDURE ON 4/1/08, WHEN THE INJURED AREA OF THE BOWEL WAS NOT IN VIEW. THIS COULD HAVE OCCURRED DURING INITIAL PLACEMENT OF THE SURGICAL PORTS, WHEN THE PT BUCKED ON THE TABLE AND THE TROCARS WERE STILL INSTALLED DURING THE SYSTEM DELAY, DURING MANIPULATION OF THE BOWEL, OR DURING AN UNOBSERVED INSERTION OF A DA VINCI S OR ASSISTANT INS
cause not established2955842-2008-01176Intuitive Surgical, Inc.Read the record ↗Not graded by the source2007-07-17FDA MAUDE2955842-2008-01470da 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 AT THE END OF A DA VINCI HYSTERECTOMY SURGICAL PROCEDURE THE SURGICAL STAFF NOTICED A "DRIED OR BURN-LIKE" AREA AROUND THE CAMERA PORT INCISION, APPROX 2MM IN WIDTH. THE DAMAGED SKIN HAD TO BE CUFF OFF IN ORDER TO CLOSE THE INCISION. NO VISUAL DAMAGE NOR SIGNS OF MELTING WERE OBSERVED ON THE CANNULA ACCESSORY USED IN CONJUNCTION WITH THE CAMERA.
cause not established2955842-2008-01470Intuitive Surgical, Inc.Read the record ↗Not graded by the source2007-07-05FDA MAUDE2955842-2010-00188da 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 04/08/2010, ISI RECEIVED VOLUNTARY MEDWATCH (B)(4) FROM THE FDA DEPARTMENT OF HEALTH AND HUMAN SERVICES REPORTING THE FOLLOWING: VOLUN 01-FEB-2010: MY NAME IS (B)(6). I AM THE PERSONAL REP OF THE ESTATE OF (B)(6), ON (B)(6) 2007, MY MOTHER HAD A DAVINCI ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY AT (B)(6) MEDICAL CENTER IN (B)(6). IT IS MY UNDERSTANDING THAT DURING THIS EVENT, DR (B)(6) LOST VISUALIZATION AND THE INSTRUMENT ON THE ROBOT CUT THE RIGHT COMMON ILIAC ARTERY LEADING TO HEMORRHAGE, CARDIOPULONARY ARREST AND NEAR EXSAGUINATION. THE INFO I HAVE BEEN PROVIDED WITH INDICATES THAT THIS MAY HAVE BEEN REPORTED TO THE FDA AS A MAUDE ADVERSE EVENT ASSOCIATED WITH THE DAVINCI SURGICAL ROBOT. I HAVE NOT BEEN ABLE TO LOCATE SUCH A REPORT DURING MY ONLINE SEARCH. PHYSICIAN: (B)(6) MD. FACILITY: (B)(6) MEDICAL CENTER. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, INCLUDING INFORMATION RELATED TO THE FIELDS IN (B)(6).
cause not established2955842-2010-00188Intuitive Surgical, Inc.Read the record ↗Not graded by the source2007-07-05FDA MAUDE2955842-2010-00144da 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 MARCH 12, 2010, ISI RECEIVED MAUDE EVENT REPORT (B) (4) WITH THE FOLLOWING EVENT DESCRIPTION: MY NAME IS XXX. I AM THE PERSONAL REP OF THE ESTATE OF XXX ON XX XX 2007, MY MOTHER HAS A DA VINCI ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY AT XXX MEDICAL CENTER IN XXX. IT IS MY UNDERSTANDING THAT DURING THIS EVENT DR XXX LOST VISUALIZATION AND THE INSTRUMENT ON THE ROBOT CUT THE RIGHT COMMON ILIAC ARTERY LEADING TO HEMORRHAGE, CARDIOPULMONARY ARREST AND NEAR EXSANGUINATION. THE INFO I HAVE BEEN PROVIDED WITH INDICATES THAT THIS MAY HAVE BEEN REPORTED TO THE FDA AS AN MAUDE ADVERSE EVENT ASSOCIATED WITH THE DA VINCI SURGICAL ROBOT. I HAVE NOT BEEN ABLE TO LOCATE SUCH A REPORT DURING MY ONLINE SEARCH. PHYSICIAN XXX. MEDICAL FACILITY XXX. NO ADDITIONAL INFORMATION WAS PROVIDED.
cause not established2955842-2010-00144Intuitive Surgical, Inc.Read the record ↗