BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16237235 · Received January 24, 2023

    Report

    Report Number
    2955842-2023-10281
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Date of Event
    December 28, 2022
    Report Date
    December 28, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THERE WAS AN M-02 ERROR ON THE ERBE AND THE GROUND PAD WOULD NOT TURN GREEN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) (PART NO: 951300-03, SERIAL NO: (B)(4)) IN ACCORDANCE WITH ISI PROCEDURES TO RESOLVE THE ISSUE. 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. THE IESU WAS ANALYZED AND REPORTED FAILURE (ERBE ERROR M-02-3 AND GROUND PAD WILL NOT TURN GREEN) WAS CONFIRMED AND REPRODUCED. THE IESU WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE GROUND PAD WOULD NOT TURN GREEN. THE PROBABLE ROOT CAUSE OF THERE WAS AN M-02 ERROR ON THE ERBE AND THE GROUND PAD WOULD NOT TURN GREEN IS ATTRIBUTED TO COMPONENT FAILURE OR THE ERBE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: ALTHOUGH THE CUSTOMER DID NOT ABORT/CONVERT AFTER THE START OF THE PROCEDURE DUE TO AN ERBE M-02 ERROR AND GROUND PAD WOULD NOT TURN, THE ISSUE WAS REPRODUCED BY THE FIELD SERVICE ENGINEER (FSE) AND FAILURE ANALYSIS (FA) INVESTIGATION. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED THE TECHNICAL SERVICE ENGINEER (TSE) AND STATED THAT THERE WAS AN M-02 ERROR ON THE ERBE AND THE GROUND PAD WOULD NOT TURN GREEN. THE CUSTOMER CLEANED THE PATIENT GROUND PAD LOCATION WITH NO CHANGE AND THEN, UNPLUGGED THE ERBE POWER CORD AND PLUGGED IT BACK IN. THE GROUND PAD THEN TURNED GREEN, BUT THEY STILL HAD A M-02 CODE. THE CUSTOMER STATED THAT THEY HAD THE M-02 CODE THE PREVIOUS DAY AS WELL, BUT IT DID NOT PREVENT ENERGY ACTIVATION. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. AN ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS. THIS COMPLAINT WILL BE CLASSIFIED BASED ON THE PROVIDED INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376320 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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