BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 18743396 · Received February 20, 2024

    Report

    Report Number
    2955842-2024-11220
    Event Type
    Injury
    Date Received
    February 20, 2024
    Date of Event
    January 22, 2024
    Report Date
    January 22, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SITE¿S SYSTEM LOGS FOUND NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. NO IMAGE(S) AND/OR VIDEO CLIP(S) WERE SUBMITTED FOR REVIEW. AN ADVANCED SYSTEM LOG REVIEW FOR THE REPORTED PROCEDURE WAS CONDUCTED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). DIGITAL SIGNAL PROCESSOR (DSP) LOGS SHOW THAT THE VESSEL SEALER (VSE) INSTRUMENT WAS INSTALLED 5 TIMES AND PASSED HOMING 5 TIMES. THERE WERE 29 CUT COMPLETE EVENTS WERE RECORDED WITH NO ERRORS. E100 LOGS SHOW 33 SEAL EVENTS WITH NO ERRORS. THE INSTRUMENT WAS USED FOR ABOUT 43 MINUTES. THE MASTER SUPERVISORY CONTROL LOGS SHOWED SOME ERRORS NOT RELATED TO A VSE FUNCTIONALITY ISSUE. A REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE PATIENT IN THIS REPORT HAD A BLEED OF AN ESTIMATED 25 CC WHEN A VESSEL SEALER FAILED TO COMPLETELY SEAL THE IMA. THE VESSEL WAS LIGATED WITH A CLIP APPLIER AND ONLY 25 CC OF BLOOD LOSS WAS REPORTED BECAUSE OF THIS FAILURE. LATER IN THE CASE, THE PATENT SUFFERED A CARDIAC EVENT. WHILE SUCH A SMALL VOLUME OF BLOOD LOSS IS NOT LIKELY TO HAVE CONTRIBUTED TO THE SUBSEQUENT CARDIAC EVENT, IT CANNOT BE COMPLETELY EXCLUDED. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT EVIDENCE IS AVAILABLE TO DETERMINE IF THE VESSEL SEALER FAILURE CONTRIBUTED TO THE CARDIAC EVENT. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER # (B)(6) FOR MDR SUBMISSION OF THE INITIAL REPORT OF THE PATIENT HAVING CARDIOPULMONARY ARREST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION, THERE WAS BLEEDING FROM THE INFERIOR MESENTERIC ARTERY (IMA). A VESSEL SEALER WAS USED TO DISSECT THE IMA, THEN IT WAS SEALED UNDER NO TENSION. THE VESSEL SEALER WAS THEN MOVED 5 MM MORE DISTALLY ON THE VESSEL, AND IT WAS SEALED AGAIN AND THEN CUT. THE IMA WAS 5 MM IN DIAMETER AND WAS NOT CALCIFIED. THE VESSEL SEALER INSTRUMENT WORKED AS EXPECTED, THERE WERE NO ERRORS ENCOUNTERED, THERE WAS NO CONTINUOUS TONE, AND THE SEAL CYCLE WAS COMPLETED BOTH TIMES WITH APPROPRIATE 3 FAST TONES. THE SURGEON FURTHER ADDED THAT THERE WAS NO DELAYED SEALING AND THERE WAS NO TISSUE THAT WAS CUT THAT WAS NOT COMPLETELY SEALED. THE SITE INITIALLY LOOKS FINE AND THEN AFTER ABOUT 15-20 MINUTES, THE IMA POPPED OPEN, AND BLOOD WAS SEEN SQUIRTING OUT OF THE STUMP OF THE SEALED VESSEL. TWO 10 MM CLIPS WERE PLACED ON THE VESSEL TO STOP THE BLEEDING. THE ESTIMATED BLOOD LOSS WAS ONLY 25 MILLILITERS (ML) AS THE BLEEDING WAS IDENTIFIED IMMEDIATELY. THE SURGEON WAS ABLE TO CONTINUE THE PROCEDURE AS THERE WAS NO FURTHER BLEEDING OBSERVED. HALFWAY THROUGH THE PROCEDURE, THE PATIENT HAD A CARDIOPULMONARY ARREST (PR 867676). THE SURGEON REPORTED THAT THE CARDIOPULMONARY ARREST WAS NOT RELATED TO THE BLEEDING FROM THE IMA. THE PROCEDURE WAS ABORTED. ON THE EVENING OF THE SURGERY, THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH EVACUATION OF HEMOPERITONEUM. THERE WERE NO ACTIVE BLEEDING AREAS FOUND, THE IMA AND THE INFERIOR MESENTERIC VEIN WERE STILL CLIPPED AND NOTED TO BE SECURED. ON SECOND POST-OPERATIVE DAY, THE PATIENT UNDERWENT RECTUM AND SIGMOID COLON REMOVAL. THE PLAN OF CARE IS TO HAVE THE PATIENT UNDERGO CREATION OF COLOSTOMY. THE SURGEON BELIEVES THAT THE HEMOPERITONEUM WAS CAUSED BY PATIENT¿S USE OF ANTICOAGULATION. THE SURGEON ALSO BELIEVE THAT THE ISSUE WAS THAT HE DID NOT "DOUBLE TAP" (RUN THE SEAL CYCLE TWICE WITHOUT LETTING UP ON THE VESSEL AND THEN CUTTING) WHICH HE NORMALLY DOES WITH THE VESSEL SEALER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088467 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K12230923 0172

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES