BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOWRIST VESSEL SEALER EXTEND

    MDR report key: 16415113 · Received February 21, 2023

    Report

    Report Number
    2955842-2023-10794
    Event Type
    Death
    Date Received
    February 21, 2023
    Date of Event
    January 27, 2023
    Report Date
    January 27, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC (ISI) DID NOT RECEIVE THE VESSEL SEALER EXTEND (VSE) INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS MEDWATCH REPORT (PATIENT IDENTIFIER (B)(6)) IS FOR THE POST-OPERATIVE BLEEDING FROM THE IMA WHERE THE VSE INSTRUMENT WAS USED AND THE SURGEON NOTED AS THE SOURCE OF THE BLEEDING DURING THE SECOND SURGERY. A SEPARATE MEDWATCH WITH PATIENT IDENTIFIER 615479 WAS REPORTED FOR THE MONOPOLAR CURVED SCISSORS AND THE DECISION TO CONVERT TO OPEN SURGERY. A REVIEW OF THE ADVANCED LOG FOR THE VESSEL SEALER EXTEND REVEALED THAT THERE WAS ONE ¿HOME COMPLETE EVENT¿ AND 6 CUT COMPLETE EVENTS, SUGGESTING THE VSE WAS INSTALLED ONCE. E-100 GENERATOR LOGS SHOW THERE WERE 13 TOTAL SEAL EVENTS, AND NONE OF THE SEAL EVENTS HAD ANY ASSOCIATED ERROR CODES. DEVICE HISTORY RECORD (DHR) REVIEWS FOR THE DEVICES INVOLVED WITH THE REPORTED EVENT SHOWED NO NON-CONFORMANCES RELATED TO THIS EVENT. MULTIPLE SUBSEQUENT PROCEDURES HAVE BEEN PERFORMED ON THIS SYSTEM WITH NO SERVICE REQUESTS BEING CREATED. ADDITIONALLY, ALL INSTRUMENTS WERE USED IN SUBSEQUENT PROCEDURES IN SUBSEQUENT EVENTS WITH THE EXCEPTION OF THE MONOPOLAR CURVED SCISSORS, WHICH WAS AT ITS LAST USAGE, AS WELL AS THE VESSEL SEALER EXTEND WHICH IS A SINGLE-USE INSTRUMENT. THE MEDICAL SAFETY OFFICER REVIEW OF THE EVENT WAS PERFORMED AND CONCLUDED THAT BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, THE VSE INSTRUMENT WAS USED ON THE IMA AND NO ERRORS WERE NOTED AT THE TIME OF SURGERY NOR WAS ANY BLEEDING OBSERVED. HOWEVER, IN THE RECOVERY ROOM AND NEARLY 1.5 HRS AFTER SURGERY, THE PATIENT EXPERIENCED A SIGNIFICANT BLEEDING EVENT WHICH REQUIRED AN EMERGENT EXPLORATION. THE PATIENT LATER EXPIRED FROM MULTISYSTEM ORGAN FAILURE. BASED ON THE INFORMATION IN THE SUMMARY OF EVENTS, THE FAILURE OF THE SEAL AT THE IMA SHORTLY AFTER SURGERY COULD HAVE CONTRIBUTED TO THIS ADVERSE EVENT AND DEATH. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: AFTER A DA VINCI-ASSISTED SIGMOID COLECTOMY, THERE WAS EXCESSIVE POST-OPERATIVE BLOOD LOSS FROM THE INFERIOR MESENTERIC ARTERY (IMA) WHERE THE VESSEL SEALER EXTEND (VSE) WAS USED TO SEAL, AN EMERGENT SURGERY WAS PERFORMED AND THE BLEEDING WAS STOPPED. THE PATIENT LATER EXPIRED FROM MULTISYSTEM ORGAN FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SIGMOID COLECTOMY ON (B)(6) 2023, THERE WAS EXCESSIVE POST-OPERATIVE BLOOD LOSS FROM THE INFERIOR MESENTERIC ARTERY (IMA), A SECOND EMERGENT SURGERY WAS PERFORMED, AND THE PATIENT LATER EXPIRED. THE SURGEON REPORTED THAT 1.5HRS AFTER THE PATIENT WAS IN POST-OPERATIVE RECOVERY FROM THE DA VINCI-ASSISTED SIGMOID COLECTOMY, THE PATIENT WENT INTO CARDIAC ARREST. RESUSCITATION WAS PERFORMED, 2 UNITS OF BLOOD WERE TRANSFUSED, AND THE PATIENT WAS RUSHED TO THE OR FOR EMERGENCY EXPLORATION SURGERY. A LARGE AMOUNT OF BLEEDING WAS DISCOVERED COMING FROM THE INFERIOR MESENTERIC ARTERY (IMA), WHICH HAD BEEN SEALED BY THE VESSEL SEALER EXTEND (VSE) INSTRUMENT. THE BLEEDING WAS CONTROLLED AND MULTIPLE ADDITIONAL BLOOD PRODUCTS WERE TRANSFUSED. THE PATIENT DIED ON (B)(6) 2023 FROM MULTIPLE ORGAN FAILURE. THE SURGEON STATED THERE WAS NO VESSEL TENSION WHILE SEALING DURING THE INITIAL SURGERY. THE IMA WAS WELL DISSECTED, ¿NICE AND SOFT¿, ALTHOUGH THE PATIENT WAS A HEAVY SMOKER. THE SURGEON USED THE VSE AS HE ALWAYS DOES AND DID NOT GET ANY ERROR MESSAGES. NO DELAYED SEALING, OR INSUFFICIENT SEALING WAS NOTED DURING THE SURGERY. THE SURGEON CONFIRMED THERE WERE AUDIBLE SIGNALS WHEN THE SEALINGS WERE COMPLETED AND THE VESSEL WAS CONFIRMED TO BE SEALED FULLY DURING THE SURGERY. NO ABNORMAL BLEEDING AND NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. INCIDENTALLY, THE SURGEON ALSO REPORTED THAT THE MONOPOLAR ENERGY WAS NOT FUNCTIONING DURING THE MIDDLE OF THE PROCEDURE AND THEY SUSPECTED A GROUNDING PAD ISSUE. THE MONOPOLAR CURVED SCISSORS COULD NOT BE USED SO THE SURGEON DECIDED TO CONVERT TO OPEN AT THAT TIME, STATING THAT MOST OF THE PROCEDURE WAS DONE AT THAT POINT. THE PATIENT ALSO REPORTEDLY TOLERATED THE CONVERSION WELL WITHOUT ANY COMPLICATIONS. NO ABNORMAL BLEEDING AND NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED AT THAT TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667139 ENDOWRIST VESSEL SEALER EXTEND VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422 K10221104 0236 10886874115661

    Patients

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