BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 16798068 · Received April 24, 2023

    Report

    Report Number
    2955842-2023-12145
    Event Type
    Injury
    Date Received
    April 24, 2023
    Date of Event
    March 27, 2023
    Report Date
    March 27, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. A PRODUCT HAS NOT BEEN RETURNED TO ISI FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. PER A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE, NO RELATED SYSTEM ERRORS OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THIS COMPLAINT IS CONSIDERED A REPORTABLE ADVERSE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THERE WAS REPORTED 600 CC OF BLOOD LOSS AND UNSPECIFIED MULTISYSTEM PROBLEMS, AND AFTER CONTACTING A SURGERY CHIEF, THE PROCEDURE WAS CONVERTED TO OPEN. NO ALLEGATION OF A MALFUNCTION WAS MADE AGAINST A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED TO INTUITIVE SURGICAL, INC, (ISI) BY THE SURGEON: THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO THE PATIENT'S ANATOMY; THIS WAS ANTICIPATED AS A POSSIBILITY PRIOR TO THE SURGERY. ABOUT 2.25 HOURS INTO THE SURGERY, THE SURGEON WAS DISSECTING THE VENA CAVA FOR A THROMBECTOMY, AND ABOUT 600 ML OF BLEEDING OCCURRED, DUE TO A CONGESTED VENA CAVA, THE DIAMETER OF THE VESSEL, ADVANCED ONCOLOGIC DISEASE, AND AN ABUNDANCE OF VESSELS IN THE AREA. THIS WAS RESOLVED BY PRIMARY CLOSURE OF THE VENA CAVA, WITH A TRANSFUSION OF 2 GLOBULAR PACKAGES. THIS BLEEDING WAS EXPECTED AS PART OF THE PROCEDURE, AND IT WAS NOT CAUSED BY ANY UNEXPECTED MOVEMENT OF AN ISI PRODUCT. THE SURGEON REPORTED THAT THERE WAS A SYSTEM/DEVICE MALFUNCTION PRIOR TO THE PROCEDURE CONVERSION, BUT WHEN ASKED TO SPECIFY, THERE WAS NO RESPONSE. THE SYSTEM WAS INSPECTED PRIOR TO USE. THE PATIENT REPORTEDLY TOLERATED THE CONVERSION WELL, AND THERE WAS NO REPORTED INJURY TO THE PATIENT AS A RESULT OF THE CONVERSION. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS, AND HE WAS DISCHARGED AFTER THE FOURTH DAY. WHEN ASKED WHICH MULTISYSTEM COMPLICATIONS OCCURRED DURING THE PROCEDURE, THERE WAS NO RESPONSE. NO IMAGES OR VIDEO RECORDINGS OF THE PROCEDURE ARE AVAILABLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, AFTER CLAMPING THE VENA CAVA AND THE RENAL VEIN AND STARTING THE TUMOR EXCISION, THE SURGEON ENCOUNTERED AN ACCESSORY RENAL VEIN THAT HE HAD NOT PREVIOUSLY CLIPPED NOR LIGATED. HE WAS UNABLE TO PROCEED WITH LIGATION DUE TO LIMITED REACH, AS THE VEIN WAS CONSIDERABLY DEEP IN THE TISSUE. THERE WAS REPORTED 600 CC OF BLOOD LOSS AND UNSPECIFIED MULTISYSTEM PROBLEMS, AND AFTER CONTACTING A SURGERY CHIEF, THE PROCEDURE WAS CONVERTED TO OPEN. THE CAUSE OF THE BLEEDING AND OF THE OTHER INTRA-OPERATIVE COMPLICATION(S), ANY SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED, AND THE PATIENT'S STATUS ARE CURRENTLY UNKNOWN. INTUITIVE SURGICAL, INC, (ISI) CONTACTED THE SITE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    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
    1520838 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES