BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14626792 · Received June 7, 2022

    Report

    Report Number
    2955842-2022-12053
    Event Type
    Injury
    Date Received
    June 7, 2022
    Report Date
    May 9, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSES OF THE OPERATIVE COMPLICATIONS CANNOT BE DETERMINED OR ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THERE WAS NO IMAGE OR VIDEO CLIP SUPPLIED FOR REVIEW RELATED TO A SPECIFIC EVENT. SYSTEM OR INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAILS. THE SPECIFIC PROCEDURE/EVENT DATES AND DA VINCI SYSTEM SERIAL #S ARE UNKNOWN. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿LEARNING CURVE IN ROBOT-ASSISTED PARTIAL NEPHRECTOMY: COMPARISON BETWEEN AN EXPERT SURGEON AND A TEAM IN TRAINING IN SINGLE-CENTER EXPERIENCES,¿ OPERATIVE COMPLICATIONS ASSOCIATED WITH DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURES ARE NOTED. A NUMBER OF THE COMPLICATIONS REQUIRED MEDICAL INTERVENTION AND IN ONE INSTANCE, A PATIENT REQUIRED ADMISSION TO INTENSIVE CARE. THE CAUSES OF THE OPERATIVE COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER (B)(6) FOR MDR SUBMISSION OF THE PATIENT DEATH NOTED WITHIN THE ARTICLE.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A CENTRAL EUROPEAN JOURNAL OF UROLOGY ARTICLE TITLED, ¿LEARNING CURVE IN ROBOT-ASSISTED PARTIAL NEPHRECTOMY: COMPARISON BETWEEN AN EXPERT SURGEON AND A TEAM IN TRAINING IN SINGLE-CENTER EXPERIENCES¿ (FIORELLO, N., DI BENEDETTO, A., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, INTRAOPERATIVE COMPLICATIONS LEADING TO PATIENT DEATH INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED. FROM JANUARY 2014 TO DECEMBER 2020, 333 PATIENTS WERE RETROSPECTIVELY ENROLLED, UNDERGOING ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN). THE FOLLOWING ELEMENTS WERE EVALUATED FOR EACH PATIENT: SURGICAL COMPLEXITY, DURATION, PERIOPERATIVE COMPLICATIONS, AND CLAMPING. PER THE ARTICLE, "COMPARISONS WERE MADE BETWEEN AN EXPERIENCED SURGEON AND 3 UROLOGISTS WITH INITIAL EXPERIENCE IN ROBOTIC SURGERY." THE FOLLOWING WAS NOTED IN THE ARTICLE: ¿INTRAOPERATIVE COMPLICATIONS OCCURRED IN 3 PATIENTS: ONE CASE FOR THE EXPERIENCED SURGEON WITH PERFORATION OF THE ILEUM, WHICH REQUIRED OPEN CONVERSION, WITH ADMISSION TO INTENSIVE CARE AND SUBSEQUENT DEATH OF THE PATIENT, ONE CASE OF SPLENIC INJURY FOR SURGEON 2, RESOLVED WITH THE APPLICATION OF TACHOSIL AND SUBSEQUENT REGULAR COURSE UNTIL DISCHARGE, AND ONE CASE OF COLON INJURY FOR SURGEON 3, RESOLVED WITH INTRACORPOREAL SUTURE AND SUBSEQUENT REGULAR COURSE UNTIL DISCHARGE.¿ ALSO, PER THE ARTICLE, POST-OPERATIVE COMPLICATIONS OCCURRED IN 14 PATIENTS. TWELVE POST-OPERATIVE COMPLICATIOS WERE ASSOCIATED WITH THE EXPERIENCED SURGEON OF WHICH EIGHT PATIENTS WERE CLAVIEN 1 AND TWO PATIENTS CLAVIEN 3 (ONE PATIENT HAD A PULMONARY EMBOLISM, TREATED WITH MEDICAL THERAPY AND ADMISSION TO INTENSIVE CARE AND ANOTHER PATIENT HAD EXTRAVASATION OF URINE, TREATED WITH DJ URETERAL CATHETER PLACEMENT). ONE PATIENT FOR SURGEON 1 EXPERIENCED ANEMIA WHICH WAS TREATED WITH BLOOD TRANSFUSION [CLAVIEN 2]) AND ONE PATIENT FOR SURGEON 3 EXPERIENCED AN UNSPECIFIED COMPLICATION (CLAVIEN 1). ON 24-MAY-2022, INTUITIVE SURGICAL, INC (ISI) RECEIVED ADDITIONAL INFORMATION ABOUT THE COMPLAINT: FOR THE PATIENT REFERENCED IN THE ARTICLE WITH THE REPORTED SPLENIC INJURY, THE AUTHOR REPORTED THAT THE PROCEDURE OCCURRED IN 2018 ON AN UNSPECIFIED DATE USING THE DA VINCI XI SURGICAL SYSTEM. THE LACERATION OCCURRED DURING THE MOBILIZATION PHASE TO REMOVE ADHESIONS BETWEEN THE SPLENIC FLEXURE AND SPLEEN AND THE APPLICATION OF TACHOSIL© WAS USED TO ADDRESS THE INJURY. THE PATIENT¿S CURRENT STATUS IS REPORTED AS ¿PATIENT CURED, DISEASE-FREE.¿ FOR THE PATIENT REFERENCED IN THE ARTICLE WITH THE REPORTED COLON INJURY, THE AUTHOR REPORTED THAT THE PROCEDURE OCCURRED IN 2018 ON THE DA VINCI XI SURGICAL SYSTEM. THE INJURY OCCURRED DURING COLON MOBILIZATION TO REMOVE ADHESIONS BETWEEN THE COLON AND ABDOMINAL WALL AND AN INTRACORPOREAL SUTURE WAS USED TO ADDRESS THE COLON INJURY. THE PATIENT¿S CURRENT STATUS IS REPORTED AS ¿PATIENT CURED, DISEASE-FREE.¿ PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED TO THE HOSPITAL'S PRIVACY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655652 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

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