BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19697474 · Received July 8, 2024

    Report

    Report Number
    2955842-2024-16449
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 10, 2024
    Report Date
    June 10, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) SPOKE TO THE CUSTOMER ABOUT THE ISSUE. THE FSE NOTED THAT THE REPORTED ISSUE WAS RESOLVED ON THE PHONE WITH ISI TECHNICAL SUPPORT. THE ISI CLINICAL SALES REPRESENTATIVE AND ISI CLINICAL TERRITORY ASSOCIATE WOULD PERFORM AN OBSERVATION DURING A CASE SETUP. 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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, ONE OF THE UNLEVEL ARMS WAS SWINGING AROUND DURING TARGETING. THE CUSTOMER NOTED THAT THE SURGEON WAS AT THE SURGEON SIDE CONSOLE (SSC) AND IT STILL DID NOT LOOK 'LEVEL.' THERE WERE NO RELATED ERRORS IN THE LOGS. THE CUSTOMER REPORTED THAT THIS HAD BEEN AN ONGOING ISSUE WITH AT LEAST 2 DIFFERENT SURGEONS AND IT DID OCCUR LAST THURSDAY WITH A DIFFERENT ENDOSCOPE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON¿S HEAD WAS IN THE SSC AT THE TIME OF THE EVENT. THE ISSUE OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SSC. THE ISSUE WAS NOT RELATED TO AN INABILITY TO MOVE THE INSTRUMENT AT ALL. THE CUSTOMER INDICATED THAT THE INSTRUMENT MOVEMENT DID SCALE WITH THE SURGEON'S CONTROL, AND THE TIMING OF THE INSTRUMENT MOVEMENT WAS APPROPRIATE. THERE WAS NO SHAKINESS/FRICTION EXPERIENCED/OBSERVED. THERE WAS NO INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE. THERE WAS NO EXTERNAL COLLISIONS. THE ISSUE WAS PERSISTENT. THE SURGEON WAS ABLE TO CONTINUE WORKING WITH THE REPORTED PROBLEM. THE CUSTOMER DID NOT SAVE THE DRAPE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142751 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-35 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES