BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19967807 · Received August 12, 2024

    Report

    Report Number
    2955842-2024-18063
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    January 24, 2024
    Report Date
    July 18, 2024
    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
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION OR REPORT THAT DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENTS. THERE IS INSUFFICIENT INFORMATION ON THE PROCEDURE DATE AND THUS A SYSTEM LOG WAS NOT AVAILABLE TO BE PERFORMED. THERE IS ALSO INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT THE PROCEDURE HAD COMPLICATION, AS DA VINCI XI SYSTEM WAS MENTIONED IN THE ARTICLE, THEREFORE, THE PRODUCT IS REPORTED AS GENERAL XI SYSTEM. SOURCE: JING, S., YANG, E., LUO, Z. ET AL. PERIOPERATIVE OUTCOMES AND CONTINENCE FOLLOWING ROBOTIC-ASSISTED RADICAL CYSTECTOMY WITH MAINZ POUCH II URINARY DIVERSION IN PATIENTS WITH BLADDER CANCER. BMC CANCER 24, 127 (2024). HTTPS://DOI.ORG/10.1186/S12885-024-11874-X

    Description of Event or Problem · 0

    DURING A REVIEW OF AN ARTICLE EVALUATED THE PERIOPERATIVE OUTCOMES AND CONTINENCE STATUS OF BLADDER CANCER PATIENTS FOLLOWING ROBOTIC ASSISTED RADICAL CYSTECTOMY (RARC) WITH MAINZ POUCH II URINARY DIVERSION (UD), THE FOLLOWING INCIDENTS WERE MENTIONED. FROM NOVEMBER 2020 TO DECEMBER 2023, 37 BLADDER CANCER PATIENTS WHO UNDERWENT RARC WITH MAINZ POUCH II UD WERE RETROSPECTIVELY ASSESSED. THE MEDIAN (RANGE) TIME TO URINARY CONTINENCE AFTER SURGERY WAS 2.3 (1.5-6) MONTHS. OF THE 37 PATIENTS, 31 (83.8%) WERE CONTINENT BOTH DURING THE DAY AND AT NIGHT, 34 (91.9%) WERE CONTINENT DURING THE DAY, 32 (86.5%) WERE CONTINENT AT NIGHT. POSTOPERATIVE COMPLICATIONS OCCURRED IN 10 (27.8%) PATIENTS, INCLUDING EARLY (LESS THAN OR EQUAL TO 30 DAYS) COMPLICATIONS IN 3 (8.3%) PATIENTS AND LATE (GREATER THAN 30 DAYS) COMPLICATIONS IN 7 (19.4%) PATIENTS, AND 8 (22.9%) CLAVIEN-DINDO GRADE III-V COMPLICATIONS. TWO DAYS AFTER SURGERY, ONE PATIENT EXPERIENCED AN ACUTE PULMONARY EMBOLISM, WAS TRANSFERRED TO THE INTENSIVE CARE UNIT, TREATED FOR THREE DAYS, AND FINALLY RECOVERED. EIGHT DAYS AFTER SURGERY, ONE PATIENT DEVELOPED AN INCISION INFECTION AND WAS TREATED CONSERVATIVELY. TWENTY DAYS AFTER SURGERY, ONE PATIENT HAD PROLONGED ILEUS AND UNDERWENT SURGICAL INTERVENTION. THREE PATIENTS DEVELOPED ENTERO-CUTANEOUS FISTULAS, TWO OF WHOM UNDERWENT ENTEROSTOMY AND ONE OF WHOM RECEIVED CONSERVATIVE TREATMENT (PERCUTANEOUS DRAINAGE) AND WERE RECOVERED. A PATIENT EXPERIENCED URETEROHYDRONEPHROSIS, WHICH WAS TREATED WITH A HOLMIUM (YAG LASER ENDOURETEROTOMY AND BALLOON DILATION, AND THE NEPHROSTOMY TUBE WAS REMOVED AFTER FOUR WEEKS; ONE PATIENT EXPERIENCED SEPTIC SHOCK AND WAS TREATED CONSERVATIVELY; ONE PATIENT HAD BILATERAL URETEROENTERIC STRICTURES, WHICH WERE TREATED WITH BILATERAL 8 F STENTS IMPLANTED FOLLOWING BALLOON DILATION; AND ONE PATIENT DEVELOPED UROSEPSIS AND WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR THREE DAYS BEFORE RECOVERING. THERE WAS NO MENTION OF ANY DA VINCI PRODUCT MALFUNCTIONED DURING ANY OF THE PROCEDURES. THE ARTICLE CONCLUDED THAT IN PATIENTS WITH BLADDER CANCER, RARC WITH MAINZ POUCH II UD HAS AN EXCELLENT CONTINENCE RATE. BECAUSE OF ITS MINIMAL INVASIVENESS, THE INTRACORPOREAL APPROACH TO MAINZ POUCH II UD IS BENEFICIAL FOR FEMALE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216755 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES