BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18156765 · Received November 16, 2023

    Report

    Report Number
    2955842-2023-20367
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    October 27, 2023
    Report Date
    October 27, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) SUGGESTED THE SITE TO REPLACE THE ENDOSCOPE WITH A DIFFERENT ONE TO RESOLVE THE ISSUE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) MOVEMENT AND THE VIEW WERE NOT CORRECT. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) ASKED THE SITE TO REPLACE THE ENDOSCOPE WITH A DIFFERENT ONE; THE IMAGE AND MOVEMENT WERE CORRECTED. THE SITE CONTINUED WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321463 DAVINCI XI ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470056 N/A

    Patients

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