BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOWRIST

    MDR report key: 11497141 · Received March 16, 2021

    Report

    Report Number
    2955842-2021-10261
    Event Type
    Death
    Date Received
    March 16, 2021
    Date of Event
    September 28, 2020
    Report Date
    February 16, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE REPORTED INJURY IS UNKNOWN AS THERE WAS NO ALLEGATION OF ANY MALFUNCTION OF AN ISI INSTRUMENT OR ACCESSORY. THE MCS INSTRUMENT PART NUMBER: 470179-N11200323-0226, WAS USED IN SUBSEQUENT PROCEDURES UP UNTIL (B)(6) 2021, AND WAS USED UNTIL IT'S LAST USE. A REVIEW OF THE SITE'S COMPLAINT HISTORY WAS PERFORMED AND THERE WERE NO OTHER COMPLAINTS RELATED TO THE MCS INSTRUMENT. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. THE LOG REVIEW SUPPORTS THE CUSTOMER CLAIM THAT THERE WAS NO PRODUCT ISSUE DURING THE CASE. ADDITIONALLY, THE MCS INSTRUMENT USED IN THE CASE WAS USED IN SUBSEQUENT PROCEDURES. AN ISI INTERNAL MEDICAL SAFETY OFFICER PROVIDED THE FOLLOWING AFTER REVIEWING THE CASE INFORMATION: AN INJURY OCCURRED TO THE RIGHT EXTERNAL ILIAC ARTERY OF THE PATIENT DURING DISSECTION OF THE URETER DURING A ROBOTIC-ASSISTED UROLOGIC PROCEDURE. THE REPAIR OF THE INJURY BY THE SURGEON MOST LIKELY CONTRIBUTED TO THE FORMATION OF THROMBUS IN THE VESSEL LEADING TO THE ISCHEMIA OF THE RIGHT LOWER EXTREMITY. AS A RESULT, THE PATIENT REQUIRED A SECOND PROCEDURE TO RESTORE BLOOD FLOW TO THE RIGHT LOWER EXTREMITY. THE PATIENT EXPIRED AFTER THE SECOND PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM THE RIGHT EXTERNAL ILIAC ARTERY. THE BLEEDING WAS CONTROLLED WITH SUTURES. POSTOPERATIVE DAY #1, THE PATIENT EXPERIENCED RIGHT LEG PAIN, AND IT WAS IDENTIFIED THAT THERE WAS ISCHEMIA, DUE TO A THROMBUS. THE INTERVENTIONAL RADIOLOGIST PERFORMED A THROMBECTOMY; HOWEVER, THE PATENT EXPIRED RIGHT AFTER THE THROMBECTOMY. HOWEVER, THERE IS NO ALLEGATION THAT THE PATIENTS POST-OPERATIVE COMPLICATION AND SUBSEQUENT DEATH WAS DUE TO A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. MOREOVER, THE MCS INSTRUMENT WAS USED IN SUBSEQUENT PROCEDURES WITH NO ISSUES REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGIC PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM THE RIGHT EXTERNAL ILIAC ARTERY. THE BLEEDING WAS CONTROLLED WITH SUTURES. POSTOPERATIVE DAY #1, THE PATIENT EXPERIENCED RIGHT LEG PAIN, AND IT WAS IDENTIFIED THAT THERE WAS ISCHEMIA, DUE TO A THROMBUS. THE INTERVENTIONAL RADIOLOGIST PERFORMED A THROMBECTOMY; HOWEVER, THE PATENT EXPIRED RIGHT AFTER THE THROMBECTOMY. ON 05-MAR-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, WHILE TRANSFERRING THE LEFT URETER TO THE RIGHT SIDE THROUGH THE INTESTINAL TRACT DURING URINARY DIVERSION IN TOTAL CYSTECTOMY, THE MCS ATTACHED TO THE RIGHT-HAND ARM3 WAS CAUGHT IN THE RIGHT EXTERNAL ILIAC ARTERY, CAUSING DAMAGE AND BLEEDING. THE RIGHT ILIAC ARTERY WAS LIGATED, AND THE BLEEDING WAS CONTROLLED. THE SURGEON STATED THAT THERE WAS NO RELATIONSHIP BETWEEN A DA VINCI PRODUCT AND THE INTRA-OPERATIVE COMPLICATION. POSTOPERATIVE DAY #1, THE PATIENT EXPERIENCED RIGHT LEG PAIN, AND THE RADIOLOGY DEPARTMENT CONFIRMED A THROMBUS. AS A RESULT, THROMBECTOMY WAS PERFORMED TWICE. HOWEVER, IT WAS STATED THAT THE PATIENT EXPERIENCED BLEEDING DURING THE THROMBECTOMY PROCEDURE AND SUBSEQUENTLY EXPIRED DUE TO THE BLEEDING THE ACTUAL DATE OF DEATH REMAINS UNKNOWN. THE SURGEON SPECULATED THAT THE CAUSE OF DEATH WAS BLEEDING FROM THROMBECTOMY BECAUSE THE PATIENT WAS SMALL, WEIGHING (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393050 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 N11200323 0226 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES