BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18293847 · Received December 8, 2023

    Report

    Report Number
    2955842-2023-21093
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    November 17, 2023
    Report Date
    November 17, 2023
    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
    FL, 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. THE FSE FOUND THAT ERROR 31221 WAS PRESENT UPON BOOT UP. THEREFORE, THEY REPLACED THE CARDCAGE AND ERRORS CEASED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). THE CARDCAGE WAS ANALYZED, AND THE REPORTED FAILURE WAS REPLICATED AND CONFIRMED. THE CARDCAGE WAS INSTALLED AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM AND THE SYSTEM STARTED UP AND FAILED WITH ERROR 31221 NODE PPD WHICH MEANS THE HARDWARE HIGHSIDE SWITCH FAULT FIELD PROGRAMMABLE GATE ARRAY (FPGA) LOGIC HAD DETECTED A FATAL LOSS OF POWER AND HIT THE FAULT REACTION LOGIC (FRL). THIS FAULT SHOWED THE FRL HAD BEEN HIT. THE SOFTWARE WOULD LOG A FAULT BEFORE OR AFTER THIS THAT WOULD SHOW WHICH HIGHSIDE SWITCH CAUSED THE FAULT. THE UNIVERSAL POWER DISTRIBUTOR (UPD) HAD FAILED, AND ALL THE ARMS HAD RED LEDS. FOR THE TEST WITH UPD TEXT FIXTURE, THE SYSTEM STARTED UP WITHOUT ANY ERROR. FA RAN POWER CYCLE 50X WITH THIS PART AND ALL PASSED. ALL THE GANTRY MOTORS MOVED THE FULL RANGE OF MOTION WITHOUT ANY ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND STATED THAT A NON-RECOVERABLE FAULT HAD OCCURRED WHILE THE SURGEON WAS OPERATING. PRIOR TO CALLING, THE CUSTOMER UNDOCKED THE SYSTEM AND PULLED AWAY FROM THE FIELD. THE SYSTEM WAS RESTARTED PRIOR TO CALLING. THE ERROR RETURNED AND THE MESSAGING AVAILABLE DIDN'T ALLOW FOR DISABLING THE BOOM/CART DRIVE. THE NON-RECOVERABLE ERROR STATED RESTART SYSTEM TO CONTINUE. THE CUSTOMER ATTEMPTED MULTIPLE EMERGENCY POWER OFFS (EPOS) ON THE PATIENT SIDE CART (PSC) WITH AND WITHOUT THE CART CONNECTED WITH THE BLUE FIBER CABLE, BUT THERE WAS NO CHANGE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54138 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-53 N/A

    Patients

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