BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 9881474 · Received March 25, 2020

    Report

    Report Number
    2955842-2020-10235
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    March 2, 2020
    Report Date
    March 2, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION CAN BE FOUND IN FIELD D4, PRIMARY PROD-UDI NO. AND H3. ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: G4, G7, H2, H6 AND H10. REFER TO D4, UNIQUE DEVICE IDENTIFIER (UDI) WHICH WAS OBTAINED FOR THE PRODUCT: (B)(4). FOR FIELD H3, THE DEVICE RETURN TO MFR FOR EVALUATION, SHOULD HAVE BEEN SET TO "YES".

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    A SYSTEM LOG REVIEW WAS PERFORMED AND THE ERROR 32029 WAS CONFIRMED, WHICH POINTS TO A MOTOR (AMPLIFIER) FAULT ON THE ICB. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED THE INSTRUMENT CONTROL BOX (ICB) DUE TO REPEATED 32035 ERRORS. FOLLOWING SERVICE, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT CONTROL BOX (ICB) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) CONFIRMED THE CUSTOMER REPORTED ISSUE AS THE ICB FAULTED WITH THE ERROR 32039 UPON STARTUP WHEN IT WAS INSTALLED INTO IN-HOUSE TEST SYSTEM. THE NON-RECOVERABLE ERROR INDICATES THAT THE ICB DETECTED MOTOR AMPLIFIER FAULT. THIS COMPLAINT IS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE (FIRST PORT INCISION) COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE THE SURGEON ENCOUNTERED REPEATED NON-RECOVERABLE 32039 FAULTS ON THE SYSTEM. THE SITE NOTICED THAT THE INSTRUMENT CONTROL BOX (ICB) HAD A RED LED PRIOR TO PLUGGING IN THE VESSEL SEALER (VS) INSTRUMENT. WHEN THE VS INSTRUMENT WAS PLUGGED INTO THE ICB, THE ERROR 32039 WAS DISPLAYED. TECHNICAL SUPPORT HAD THE SURGICAL STAFF PERFORM TROUBLESHOOTING STEPS: HARD POWER CYCLE THE VISION SIDE CART (VSC) AND ICB, VERIFY ALL CONNECTIONS, AND POWER UP THE SYSTEM. THE SYSTEM FAULTED AGAIN UPON POWER UP AND TECHNICAL SUPPORT ADVISED THE USER TO POWER CYCLE THE ICB AND THE SYSTEM AGAIN. WHEN THE SYSTEM POWERED UP, IT FAULTED WITH ERROR 32039 AGAIN, AND THE SURGEON OPTED TO COVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI REPRESENTATIVE THAT WAS PRESENT FOR THE CASE AND CONFIRMED THAT THE PATIENT TOLERATED THE LAPAROSCOPIC SURGERY AND THERE WAS NO REPORTED PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342091 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-11 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES