BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 14325490 · Received May 7, 2022

    Report

    Report Number
    2955842-2022-11454
    Event Type
    Death
    Date Received
    May 7, 2022
    Date of Event
    May 29, 2020
    Report Date
    May 29, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI INTERNAL MEDICAL SAFETY OFFICER PROVIDED THE FOLLOWING AFTER REVIEWING THE CASE INFORMATION: WHILE PLACING AN ISI 8 MM CANNULA AND BLADELESS OBTURATOR WITH DIRECT VISUALIZATION TO GAIN PERITONEAL ACCESS FOR A PLANNED DA VINCI-ASSISTED INGUINAL HERNIA REPAIR THE SURGEON INJURED THE PATIENT¿S AORTA. THE PATIENT EXPIRED AS A RESULT OF THE INJURY. ACCORDING TO THE INFORMATION PROVIDED, THE SURGEON HAD DIFFICULTY IDENTIFYING THE ANATOMY UPON WHILE PLACING THE ISI 8 MM CANNULA AND BLADELESS TROCAR, AS NOTED BY THE FOLLOWING COMMENTS: ¿DURING INSERTION, THE SURGICAL STAFF COULD NOT TELL WHAT THEY WERE LOOKING AT IN THE SCREEN. THEY COULD NOT TELL IF THE SURGEON WAS IN ADHESIONS OR OMENTUM. ¿MOST ACCESS-RELATED FATALITIES FOLLOWING MINIMALLY INVASIVE SURGERY ARE DUE TO VASCULAR OR GASTROINTESTINAL INJURY RELATED TO USER TECHNIQUE. MAJOR VASCULAR INJURY DURING ACCESS FOR MINIMALLY INVASIVE SURGERY OCCURS IN 0.3 TO 1.0 PERCENT OF PROCEDURES. INJURY TO THE AORTA OR ILIAC VESSELS DURING ACCESS CAN LEAD TO RAPID EXSANGUINATION AND DEATH. UNDER GENERAL ANESTHESIA, THE ABDOMINAL WALL CAN LIE DIRECTLY OVER THE AORTA WHICH CAN BE EASILY INJURED DURING THE PLACEMENT ANY CANNULA AND OBTURATOR. SURGEONS NEED TO CONSIDER USING ALTERNATIVE APPROACHES TO GAIN PERITONEAL ACCESS IF ANATOMICAL LANDMARKS ARE UNABLE TO BE CLEARLY IDENTIFIED. CONDITIONS THAT MAY REQUIRE AN ALTERNATIVE APPROACH FOR MINIMALLY INVASIVE ACCESS INCLUDE, BUT NOT LIMITED TO, PRESENCE OF AN UMBILICAL HERNIA, PRIOR ABDOMINAL WALL SURGERY, OBESITY AND PREGNANCY. THE CAUSE OF THE PATIENT¿S MORTALITY IS DUE TO HYPOPERFUSION FROM MASSIVE BLOOD LOSS RESULTING FROM AN AORTIC INJURY DUE TO MISIDENTIFICATION OF ANATOMICAL LANDMARKS DURING THE PLACEMENT OF AN 8 MM CANNULA AND BLADELESS OBTURATOR BY THE SURGEON. I AGREE WITH THE ASSESSMENT OF THE SURGEON AND 2 OTHER UNIDENTIFIED PHYSICIANS WHO DISCUSSED THE CASE WITH HER, THERE IS NO BELIEF OR ALLEGATION THAT THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY TO THE AORTA AND SUBSEQUENT DEATH. A SYSTEM LOG REVIEW CANNOT BE PERFORMED SINCE THE DA VINCI SURGICAL SYSTEM WAS NOT DOCKED TO THE PATIENT AT THE TIME OF THE EVENT AND WAS NOT IN USE. NO IMAGES OR VIDEO WERE PROVIDED FOR ISI¿S EVALUATION. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: WHILE IT WAS REPORTED THAT THERE WAS NO BELIEF OR ALLEGATION THAT THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, THE SURGEON STRUCK THE PATIENT¿S AORTA WITH AN ISI CANNULA AND OBTURATOR, WHICH LED TO BLEEDING AND THE SUBSEQUENT DEATH OF THE PATIENT. AT THIS TIME, IT IS UNKNOWN WHY EXACTLY THE AORTA WAS STRUCK UPON CANNULA/OBTURATOR ENTRY. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION IS NOT APPLICABLE. FIELD IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION IS NOT AVAILABLE. FIELD IS BLANK BECAUSE INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT DURING A PLANNED DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE SURGEON STRUCK THE PATIENT¿S AORTA WITH A CANNULA AND OBTURATOR. AT THE TIME THE EVENT OCCURRED, THE SURGEON HAD MADE THE FIRST INCISION IN THE ABDOMEN AND WAS PLACING THE CANNULA INTO THE PATIENT. THE PATIENT EXPIRED ON THE TABLE. THE DA VINCI SYSTEM WAS NOT DOCKED TO THE PATIENT AND WAS NOT IN USE YET AT THE TIME. IT WAS NOTED THAT THE SURGEON DID NOT BELIEVE AN INTUITIVE SURGICAL, INC. (ISI) DEVICE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. ON (B)(6) 2020, THE REGISTERED NURSE (RN) SITE SUPERVISOR IN THE DOCTOR¿S OFFICE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: SHE INDICATED THAT PER THE SURGEON AND 2 OTHER UNIDENTIFIED PHYSICIANS WHO DISCUSSED THE CASE WITH HER, THERE IS NO BELIEF OR ALLEGATION THAT THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY TO THE AORTA AND SUBSEQUENT DEATH. THE RN SITE SUPERVISOR CONFIRMED THAT NO MALFUNCTION OF THE ISI CANNULA OR OBTURATOR OCCURRED. SHE INDICATED THAT THE ROBOT WAS NEVER DOCKED TO THE PATIENT, AND SHE FELT CONFIDENT STATING THAT THE DA VINCI SURGICAL SYSTEM HAD NOTHING TO DO WITH THE PATIENT'S DEATH AND THAT FURTHER INVESTIGATION WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067581 NONE CANNULA, STANDARD, REUSABLE NAY INTUITIVE SURGICAL, INC 470002-08 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES