BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 15031864 · Received July 15, 2022

    Report

    Report Number
    2955842-2022-12972
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    June 16, 2022
    Report Date
    June 17, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. ISI HAS NOT RECEIVED THE INSTRUMENT INVOLVED WITH THIS EVENT FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. THE LOGS SHOW THAT THE ONLY BIPOLAR INSTRUMENT USED DURING THE CASE WAS A FENESTRATED BIPOLAR FORCEPS INSTRUMENT (PART #471205-17; LOT #K1120110-0006). PER THE LOGS, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS USED FOR A DURATION OF 1 HOUR AND 23 MINUTES DURING THE PROCEDURE. THE LOGS ALSO SHOW THAT THIS FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS USED IN A SUBSEQUENT SURGICAL PROCEDURE AND REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED NO OTHER COMPLAINTS RELATED TO THIS PRODUCT/EVENT. NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENT WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE, AN AORTIC BLEED OCCURRED. THE ESTIMATED BLOOD LOSS AND CAUSE OF THE BLEED ARE UNKNOWN. THE ISSUE OCCURRED WHEN THE BIPOLAR INSTRUMENT WOULD NOT FIRE, DELAYING COAGULATION. THE CUSTOMER BELIEVES THE CAUSE OF THE ISSUE WAS DUE TO BLUE BIPOLAR ENERGY CORD WHICH WAS REPLACED TWICE DURING THE CASE, BUT DID NOT RESOLVE THE ISSUE. THE SURGEON USED MONOPOLAR ENERGY TO CONTROL THE BLEED. THE SURGERY WAS COMPLETED ROBOTICALLY WITHOUT BIPOLAR ENERGY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE, AN AORTIC BLEED OCCURRED. THE ESTIMATED BLOOD LOSS AND CAUSE OF THE BLEED ARE UNKNOWN. AT THE TIME THE COMPLICATION OCCURRED, THE CUSTOMER INDICATED THAT BIPOLAR ENERGY WOULD NOT FIRE FROM THE BIPOLAR INSTRUMENTS WHICH CAUSED A DELAY WITH COAGULATION. ACCORDING TO THE CUSTOMER, THE CAUSE OF THE ENERGY ISSUE WAS DUE TO THE BLUE, BIPOLAR ENERGY CORD. THE INITIAL BIPOLAR CORD WAS REPLACED TWICE BUT THIS DID NOT RESOLVE THE ISSUE. A BLOOD TRANSFUSION WAS NOT ADMINISTERED. THE SURGEON USED MONOPOLAR ENERGY TO COAGULATE THE AORTIC BLEED. THE SURGERY WAS COMPLETED ROBOTICALLY WITHOUT BIPOLAR ENERGY. INTUITIVE SURGICAL, INC. (ISI) MADE THE REQUIRED FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256988 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-28 N/A 00886874110898

    Patients

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