BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 12523092 · Received September 23, 2021

    Report

    Report Number
    2955842-2021-11177
    Event Type
    Injury
    Date Received
    September 23, 2021
    Report Date
    August 30, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED INCIDENT CANNOT BE DETERMINED OR IS UNKNOWN. THERE WAS NO REPORT OR ALLEGATION FROM THE CUSTOMER OF A DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION, OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. ISI HAS ATTEMPTED TO FOLLOW-UP TO GATHER ADDITIONAL INFORMATION. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SITE HISTORY REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A SYSTEM LOG REVIEW CANNOT BE PERFORMED AT THIS TIME SINCE THE EVENT DATE, SURGEON NAME AND PROCEDURE DETAILS ARE UNKNOWN. NOIMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: ALTHOUGH IT WAS MENTIONED THAT THE PATIENT SUFFERED FROM RIGHT RENAL INSUFFICIENCY AND LOWER GFR RATE, SECONDARY TO ACCIDENTAL INJURY DURING THE PROCEDURE FROM UNEXPOSED SIGHT OF THE RIGHT RENAL ARTERY, WE ARE UNABLE TO CONFIRM IF THERE WAS ANY USE ERROR OR ISI PRODUCT MALFUNCTION. ADDITIONALLY, THE PATIENT SUFFERED 2000ML OF BLOOD LOSS AND UNDERWENT A BLOOD TRANSFUSION. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE COMPLICATIONS AS WELL AS THE MEDICAL/ SURGICAL INTERVENTION RENDERED, IF ANY, ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE OPERATIVE COMPLICATION.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A TRANSLATIONAL ANDROLOGY AND UROLOGY ARTICLE TITLED, ¿ROBOT-ASSISTED LAPAROSCOPIC RETROPERITONEAL LEIOMYOSARCOMA RESECTION WITH INFERIOR VENA CAVA GRAFT REPLACEMENT: A CASE REPORT¿ (CHENG, G., RUAN, H., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: "OWING TO THE UNEXPOSED SIGHT OF RIGHT RENAL ARTERY, THE ACCIDENTAL INJURY OCCURRED INTRAOPERATIVELY AND THUS THE PATIENT SUFFERED FROM RIGHT RENAL INSUFFICIENCY WITH LOWER GFR RATE." ADDITIONAL INFORMATION OBTAINED FROM THE ARTICLE: THE ESTIMATED BLOOD LOSS DURING THE PROCEDURE WAS ABOUT 2,000 ML AND THE PATIENT WAS TRANSFUSED BLOOD PLASMA WITH 600 ML INTRAOPERATIVELY. THE PATIENT WAS GIVEN AN INFUSION OF HEPARIN (AN ANTICOAGULANT) INTRA-OPERATIVELY. MRI DONE AT 1 WEEK POST-OPERATIVELY SHOWED THAT THE CONTINUITY OF RIGHT RENAL ARTERY IMAGING WAS INTERRUPTED AND SIGNALING OF THE RIGHT KIDNEY WAS WEAKER THAN THE LEFT ONE, WHICH IMPLIED STRICTURE OF RIGHT RENAL ARTERY. DURING THE 3-MONTH FOLLOW-UP OF THE PATIENT, DYNAMIC RENOGRAPHY REVEALED THAT GFR OF THE RIGHT KIDNEY WAS SIGNIFICANTLY DECREASED TO 27.4 ML/MIN, WHICH INDICATED RIGHT RENAL INSUFFICIENCY. HOWEVER, THE SERUM CREATININE AND TOTAL GFR REVERSED TO THE NORMAL LEVEL JUST 2 DAYS POSTOPERATIVELY. ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420861 DA VINCI PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR DA VINCI INSTRUMENTS AND ACCESSORIES