BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14055775 · Received April 8, 2022

    Report

    Report Number
    2955842-2022-10946
    Event Type
    Injury
    Date Received
    April 8, 2022
    Report Date
    March 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
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSES OF THE REPORTED COMPLICATIONS AFTER UNDERGOING RALP CANNOT BE DETERMINED OR IS 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 DETAIL. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿ROBOTIC-ASSISTED LAPAROSCOPIC PYELOPLASTY (RALP), FOR URETEROPELVIC JUNCTION OBSTRUCTION (UPJO), IS AN ALTERNATIVE TO OPEN PYELOPLASTY IN THE PEDIATRIC POPULATION," IT IS NOTED THAT 8 POST-OPERATIVE COMPLICATIONS OCCURRED. THE CAUSES OF THE PATIENTS' COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE COMPLICATIONS.

    Description of Event or Problem · 0

    ON 09-MAR-2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A "JOURNAL OF ROBOTIC SURGERY" ARTICLE TITLED, ¿ROBOTIC-ASSISTED LAPAROSCOPIC PYELOPLASTY (RALP), FOR URETEROPELVIC JUNCTION OBSTRUCTION (UPJO), IS AN ALTERNATIVE TO OPEN PYELOPLASTY IN THE PEDIATRIC POPULATION¿ (COHEN, S., RAISIN, G., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED. THE CLINICAL ARTICLE CITED THAT STUDY DATA WAS COLLECTED BASED ON A RETROSPECTIVE REVIEW OF RECORDS OF ALL PATIENTS WITH UPJO WHO UNDERWENT RALP AT A SINGLE INSTITUTION BETWEEN DECEMBER 2016 AND APRIL 2021. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF RALP FOR UPJO IN A HETEROGENOUS PEDIATRIC POPULATION. THE STUDY EXAMINED TWO GROUPS: LOW-WEIGHT CHILDREN (<10KG) AND THOSE WHO UNDERWENT RALP AFTER FAILED PYELOPLASTY. WITHIN THE JOURNAL ARTICLE, 8 POST-OPERATIVE COMPLICATIONS WERE NOTED. TWO PATIENTS EXPERIENCED FAILED RALP WITH ONE PATIENT REQUIRING A REDO RALP, AND SIX PATIENTS HAD CLAVIEN-DINDO GRADE I-II COMPLICATIONS (URINARY TRACT INFECTIONS (5), POST-OPERATIVE PARALYTIC ILEUS (1)). ONE PATIENT EXPERIENCED A CLAVIEN-DINDO GRADE IIIB COMPLICATION (I.E. STRICTURE OF ANASTOMOSIS). ONE OTHER PATIENT EXPERIENCED AN UNSPECIFIED CLAVIEN-DINDO GRADE IIIB COMPLICATION. NINETY-EIGHT PERCENT OF THE PATIENTS SHOWED IMPROVEMENT OR STABLE HYDRONEPHROSIS ON POSTOPERATIVE IMAGING, WITH A BETTER DRAINAGE CURVE ON DYNAMIC RADIONUCLIDE SCANS. THE AUTHORS CONCLUDED THAT PEDIATRIC PATIENTS WITH UPJO MAY BENEFIT FROM RALP AS A UNIVERSAL APPROACH. ISI HAS ATTEMPTED TO CONTACT THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION, BUT HAS NOT YET RECEIVED A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188711 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A

    Patients

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