BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOWRIST

    MDR report key: 14131805 · Received April 16, 2022

    Report

    Report Number
    2955842-2022-11091
    Event Type
    Death
    Date Received
    April 16, 2022
    Date of Event
    March 18, 2022
    Report Date
    April 25, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISFA2022-01-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE POST-OPERATIVE COMPLICATION CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, 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. ADDITIONALLY, ALL INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES. NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENT WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED NO OTHER COMPLAINTS RELATED TO THIS PRODUCT/EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER A DA VINCI-ASSISTED SIGMOID COLECTOMY, THE PATIENT RETURNED TO THE OPERATING ROOM FOR AN OPEN PROCEDURE DUE TO BLEEDING FROM THE IMA STUMP. AT THIS TIME, THE ROOT CAUSE OF THE POSTOPERATIVE COMPLICATION IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    ON 25-APR-2022, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE LOGS WERE REVIEWED BY AN INTUITIVE SURGICAL, INC. (ISI) ADVANCED FAILURE ANALYSIS (AFA) ENGINEER AND THE FOLLOWING FINDINGS WERE OBTAINED: THE LOGS SHOW A COUPLE OF ENGAGEMENT FAILURES INVOLVING THE VESSEL SEALER EXTEND INSTRUMENT, BUT NO ERRORS RELATED TO CUTTING/SEALING USAGE OF THE INSTRUMENT. ON 10-MAY-2022, ISI CONTACTED THE PHYSICIAN DIRECTLY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, THE SURGEON STATED THAT HE IS NOT COMFORTABLE SHARING INFORMATION AND ANSWERING QUESTIONS ABOUT THE EVENT AND NO FURTHER DETAILS WILL BE SHARED ABOUT THE EVENT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT: THE PATIENT REPORTEDLY EXPIRED ON (B)(6) 2022. SUMMARY CHRONOLOGY: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED SIGMOID COLECTOMY PROCEDURE ON (B)(6) 2022 AND AFTER UNDERGOING A SUBSEQUENT OPEN PROCEDURE FOR RE-EXPLORATION THE SAME DAY DUE TO BLEEDING FROM THE IMA (INFERIOR MESENTERIC ARTERY) STUMP, THE PATIENT EXPIRED. DURING THE OPEN PROCEDURE, THE BLEEDING WAS ADDRESSED, AND THE PATIENT WAS IN THE HOSPITAL AND DISCHARGED ON POST-OPERATIVE DAY (POD) 8. THE SURGEON STATED THAT THERE WERE CONCERNS WITH THE VESSEL SEALER EXTEND (VSE) INSTRUMENT, BUT NO FURTHER DETAILS. THE PATIENT WAS READMITTED 9 DAYS LATER (POD 17) FOR REASONS UNKNOWN. 10-MAY-2022, DURING REPEAT FOLLOW-UP WITH THE SURGEON REQUESTING ADDITIONAL INFORMATION, THE SURGEON STATED THAT HE WAS NOT COMFORTABLE SHARING INFORMATION OR ANSWERING QUESTIONS ABOUT THE EVENT, AND NO FURTHER DETAILS WOULD BE SHARED ABOUT THE EVENT, INCLUDING THE PATIENT OUTCOME. APPROXIMATELY 4 MONTHS LATER, ON 23-SEP-2022, DURING DISCUSSIONS WITH A DIFFERENT PHYSICIAN REGARDING THE VSE AND AN UNRELATED EVENT, THE ISI CLINICAL SALES MANAGER WAS INFORMED THAT THE PATIENT FOR THIS EVENT (ON (B)(6) 2022 PROCEDURE) HAD EXPIRED. ADDITIONAL FOLLOW-UP WITH THE ISI SPECIALTY SALES MANAGER DETERMINED THAT THE PATIENT EXPIRED ON (B)(6) 2022 AND THE ORIGINAL SURGEON REPORTED THAT THE DEATH WAS UNRELATED TO THE ROBOTIC PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER A DA VINCI-ASSISTED SIGMOID COLECTOMY, THE INFERIOR MESENTERIC ARTERY (IMA) STUMP OF A PATIENT WAS BLEEDING. THE REPORTED COMPLICATION RESULTED IN THE PATIENT RETURNING TO THE OPERATING ROOM AND UNDERWENT AN OPEN SURGICAL PROCEDURE TO CONTROL THE BLEEDING. THE PATIENT¿S REPORTED CONDITION IS STABLE. THE SURGEON REPORTED CONCERNS REGARDING INSUFFICIENT SEALING OF THE VESSEL SEALER EXTEND (VSE) INSTRUMENT. INTUITIVE SURGICAL, INC (ISI) HAS REACHED OUT TO THE SURGEON FOR ADDITIONAL INFORMATION, BUT NO RESPONSE HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174661 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 M90210817 368 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES.