BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19329640 · Received May 16, 2024

    Report

    Report Number
    2955842-2024-14511
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 12, 2024
    Report Date
    April 17, 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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE STENOSIS. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE SHOWED THAT NO RELATED SYSTEM ERRORS OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PERITONEAL CLOSURE OF A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE PATIENT'S URETER WAS ACCIDENTALLY CAUGHT WITH A NEEDLE USED FOR PERITONEAL CLOSURE, RESULTING IN STENOSIS. THE PATIENT UNDERWENT ANOTHER EMERGENCY SURGERY ON POSTOPERATIVE DAY 3, AND THE STENOSIS WAS RESOLVED BY REMOVING THE SUTURES AND PERFORMING THE PERITONEAL CLOSURE AGAIN. THE PATIENT RECOVERED WELL AFTER THE SURGERY, WITH NO FURTHER COMPLICATIONS, AND THEY WERE DISCHARGED. PER THE CUSTOMER, NO MALFUNCTION OF A DA VINCI DEVICE OCCURRED PRIOR TO OR AT THE TIME OF THE EVENT, AND THE DA VINCI DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE STENOSED URETER. THE PATIENT'S ANATOMY DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619065 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-54 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES