BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI SI

    MDR report key: 13972016 · Received March 31, 2022

    Report

    Report Number
    2955842-2022-10836
    Event Type
    Death
    Date Received
    March 31, 2022
    Date of Event
    March 3, 2022
    Report Date
    March 3, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110690
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED INTRA-OPERATIVE COMPLICATION AND SUBSEQUENT DEATH 2 YEARS POST-OPERATIVELY CANNOT BE DETERMINED OR IS UNKNOWN. AS A RESULT, NO PRODUCTS ARE EXPECTED FOR RETURN FOR FAILURE ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SITE HISTORY COMPLAINT REVIEW WAS UNABLE TO BE CONDUCTED AT THIS TIME DUE TO LACK OF INSTRUMENT DETAIL AND LACK OF SPECIFIC EVENT/PROCEDURE DETAIL. NO IMAGE FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. SYSTEM OR INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAIL. A MEDICAL REVIEW OF THE EVENT INFORMATION HAS BEEN PERFORMED BY AN ISI MEDICAL SAFETY OFFICER AND THE FOLLOWING WAS NOTED: "BASED UPON THE INFORMATION IN THE DESCRIPTION OF EVENTS, THE SUPERIOR MESENTERIC ARTERY (SMA) WAS MISIDENTIFIED TRANSECTED AND LIGATED DURING A DA VINCI ASSISTED LEFT NEPHRECTOMY TO REMOVE A 12 CM UPPER POLE, MEDIALLY LOCATED, MASS. THE SMA WAS REPAIRED BY A VASCULAR SURGEON. THE PROCEDURE DURATION WAS EXTENDED BY APPROXIMATELY ONE HOUR. THE NEPHRECTOMY PROCEDURE WAS THAN COMPLETED. IN THE ARTICLE, THE SURGEON ATTRIBUTES THE ACCIDENTAL LIGATION OF THE SMA DUE TO ANATOMICAL VARIATION, THE LEFT RENAL ARTERY ¿TAKE-OFF¿ [FROM THE AORTA] WAS HIGHER THAN THE SMA. DESPITE IMMUNOTHERAPY, THE PATIENT DEVELOPED LUNG METASTASIS SIX (6) MONTHS AFTER THE PROCEDURE AND EVENTUALLY PASSED AWAY ABOUT TWO YEARS AFTER THE PROCEDURE. THE PATIENT¿S DEATH IS MOST LIKELY ATTRIBUTED TO THE METASTATIC DISEASE. THERE IS NO REPORT NOTED THAT THE PATIENT SUFFERED ANY COMPLICATIONS DUE TO THE INJURY AND REPAIR OF THE SMA. THE BOWEL WAS INSPECTED AND REMAINED ¿HEALTHY¿ THROUGHOUT THE PROCEDURE. THE PATIENT WAS PLACED ON DALTEPARIN DURING THE HOSPITALIZATION AND ASPIRIN FOR THREE MONTHS POSTOPERATIVELY." ALTHOUGH THE AUTHOR ATTRIBUTES THE CAUSE OF THE ACCIDENTAL LIGATION DUE TO MISIDENTIFICATION OF THE SMA DUE TO ANATOMICAL VARIATION, THE DEGREE TO WHICH THE DA VINCI SYSTEM, INSTRUMENTATION, AND/OR ACCESSORIES CONTRIBUTED TO THE EVENT IS UNCLEAR." ON 03-MAR-2022, A VIDEO CLIP PROVIDED OF THE EVENT WAS REVIEWED BY AN ISI CLINICAL DEVELOPMENT ENGINEER. THE FOLLOWING INFORMATION WAS PROVIDED: A SERIES OF VESSELS WERE SKELETONIZED, LIGATED, AND TRANSECTED WITHOUT ANY ISSUES NOTED. A SURGEON ERROR RESULTED IN ACCIDENTAL LIGATION AND TRANSECTION OF THE SMA. THERE WERE NO PRODUCT ISSUES (IN THE VIDEO OR ALLEGED IN THE DESCRIPTION). THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿SUPERIOR MESENTERIC ARTERY INJURY DURING ROBOT-ASSISTED LAPAROSCOPIC NEPHRECTOMY: A ROBOTIC NIGHTMARE,¿ IT IS NOTED THAT THE PATIENT'S SMA WAS MISIDENTIFIED, AND ACCIDENTALLY LIGATED WITH HEM-O-LOCK CLIPS, AND TRANSECTED. DURING ROBOTIC-ASSISTED RADICAL NEPHRECTOMY. VASCULAR SURGICAL ASSISTANCE WAS REQUIRED. IN ADDITION, A CONVERSION TO OPEN SURGERY ALLOWED A PRIMARY VASCULAR ANASTOMOSIS TO BE MADE. THE ARTICLE REPORTS THAT THE PATIENT DEVELOPED LUNG METASTASES AT 6 MONTHS POST-OPERATIVELY AND PASSED AWAY 2 YEARS AFTER THEIR SURGERY DESPITE IMMUNOTHERAPY. AT THIS TIME, THE ROOT CAUSE OF THE PATIENT¿S INTRA-OPERATIVE COMPLICATION AND SUBSEQUENT DEATH IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRED.

    Description of Event or Problem · 0

    ON 03-MAR-2022, INTUITIVE SURGICAL, INC (ISI) BECAME AWARE OF A EUROPEAN UROLOGY OPEN SCIENCE JOURNAL ARTICLE TITLED, ¿SUPERIOR MESENTERIC ARTERY INJURY DURING ROBOT-ASSISTED LAPAROSCOPIC NEPHRECTOMY: A ROBOTIC NIGHTMARE¿ (MAYOR, N., SAPRE, N., ET AL. 2022). THE ARTICLE CITED THE INDICATION FOR SURGERY WAS THE PRESENCE OF A RENAL MASS. WITHIN THE JOURNAL ARTICLE, THE FOLLOWING OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE AND SUPERIOR MESENTERIC ARTERY (SMA) WAS NOTED: A PATIENT ¿UNDERWENT A ROBOT-ASSISTED LAPAROSCOPIC NEPHRECTOMY FOR A 12-CM UPPER POLE, MEDIALLY LOCATED, RENAL MASS. AFTER GENERAL ANAESTHESIA, APPROPRIATE PATIENT POSITIONING, AND PORT PLACEMENT, THE DESCENDING COLON WAS MOBILISED. THE URETER AND GONADAL VEIN WERE FOLLOWED TO THE HILUM. SIGNIFICANTLY DISTORTED ANATOMY WAS ENCOUNTERED DUE TO THE LARGE TUMOUR. THE SMA, WHICH WAS LOCATED JUST SUPERIOR TO THE RENAL VEIN, WAS INCORRECTLY IDENTIFIED AS THE RENAL ARTERY LIGATED WITH HEM-O-LOK CLIPS, AND DIVIDED (SEE SUPPLEMENTARY VIDEO). THIS WAS RECOGNIZED IMMEDIATELY UPON FURTHER HILAR DISSECTION, AND VASCULAR SURGEON ASSISTANCE WAS REQUESTED IMMEDIATELY. NEPHRECTOMY WAS PERFORMED AFTER LIGATION AND DIVISION OF THE TRUE RENAL ARTERIES AND VEIN.¿ ADDITIONALLY, PER THE ARTICLE, ¿ON REVIEW OF THE IMAGING, THE LEFT RENAL ARTERY TAKE-OFF WAS HIGHER THAN THE SMA, WHICH REPRESENTS AN ANATOMICAL VARIANT AND MAY HAVE CONTRIBUTED TO THE ACCIDENTAL LIGATION OF THE SMA.¿ THE ARTICLE REPORTS THE PATIENT DEVELOPED LUNG METASTASES AT 6 MONTHS AND PASSED AWAY 2 YEARS AFTER THEIR SURGERY DESPITE IMMUNOTHERAPY. 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
    783026 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-14 N/A 00886874110690

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown DA VINCI INSTRUMENTS AND ACCESSORIES