BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18820164 · Received March 1, 2024

    Report

    Report Number
    2955842-2024-11896
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    January 31, 2024
    Report Date
    January 31, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE ISI FSE REPLACED THE POWER SUPPLY SWITCHERS (PSS) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE UNITS (K1923141 AND K1923024) WERE ANALYZED AND FOUND TO HAVE NO FAILURE. BOTH COMPONENTS WERE INSTALLED ONTO THE TEST SYSTEM AND UPON STARTUP THE COMPONENTS BEHAVED NORMALLY, CURRENT AND VOLTAGE WERE WITHIN THEIR NORMAL LIMITS AND THE ERROR FILE WAS CHECKED FOR ANY SIGNS OF BATTERY FAILING WITHOUT ANY ISSUES. THE SYSTEM WAS LEFT TO IDLE FOR 10 MINUTES, THEN SET TO POWER CYCLE. NO SIGNIFICANT ERRORS OR BEHAVIOR CAME UP. THE UNITS CONTINUED TO BEHAVE NORMALLY. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION AND THE FAILURE ANALYSIS. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THE PATIENT SIDE CART (PSC) WAS RUNNING ON BATTERY MESSAGE. THE CUSTOMER CONVERTED THE CASE TO A LAPAROSCOPIC PROCEDURE. THEY TRIED MULTIPLE WORKING OUTLETS WITH NO CHANGE. THE CUSTOMER VERIFIED THAT THE PSC BREAKER WAS IN THE UP POSITION. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306819 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A

    Patients

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