BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14247069 · Received April 28, 2022

    Report

    Report Number
    2955842-2022-11302
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    March 29, 2022
    Report Date
    March 29, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 COMPLAINT. THE FSE INSPECTED THE SURGEON SIDE CONSOLE (SSC) FOR ANY EXPOSED WIRING AND DID NOT FIND ANY. THE COVERS WERE REMOVED AND WIRING AT THE HEAD SENSORS WAS INSPECTED. THE FSE PERFORMED AN ELECTRICAL SAFETY TEST WHICH MET SPECIFICATIONS. A SYSTEM TEST DRIVE WAS PERFORMED WITH MONOPOLAR AND BIPOLAR TESTS WITH HEAD IN SENSORS. NO ISSUES WERE NOTED. THE CUSTOMER HAS A PLASTIC TRAY ATTACHED TO THE ARM REST WHICH IS MOUNTED WITH THREE CLAMPS. UNABLE TO REPRODUCE REPORTED PROBLEM. SYSTEM TESTED AND VERIFIED AS READY FOR USE. ADDITIONAL INFORMATION WAS PROVIDED BY THE FSE FOLLOWING THE SITE VISIT. THERE WERE NO SIGNS OF WEAR ON THE HEADREST OF THE SSC. THERE WAS NO DISCOLORATION ON THE PLASTIC COVERS WHERE THE WIRING IS, AND THERE WERE NO SIGNS OF THERMAL DAMAGE. A LOG REVIEW COULD NOT BE PERFORMED AS THERE WAS NOT ENOUGH INFORMATION PROVIDED TO IDENTIFY WHICH OF THE PROCEDURES FROM THAT DATE WAS ASSOCIATED WITH THIS RECORD. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. THIS COMPLAINT IS CONSIDERED AS A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE SURGEON FELT AN ELECTRIC SHOCK AT THE SURGEON SIDE CONSOLE (SSC). WHILE THERE WAS NO HARM OR INJURY TO THE SURGEON OR THE PATIENT, THE REPORTED ISSUE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON FELT A 'SHOCK' WHEN OPERATING AT THE SURGEON SIDE CONSOLE (SSC). THE CUSTOMER STATED THIS OCCURRED TWICE ABOUT 20 SECONDS APART AND OCCURRED WHEN CALLING FOR MONOPOLAR OR BIPOLAR ENERGY. THE CUSTOMER WAS UNSURE OF WHICH ENERGY TYPE THE SHOCK OCCURRED WITH AS BOTH WERE IN USE AT TIME OF OCCURRENCE. THE CUSTOMER DESCRIBED THE 'SHOCK' AS POSSIBLY ORIGINATING FROM THE SURGEON HEAD AREA AND FELT THROUGHOUT HER BODY. THERE WAS NO MENTION OF ISSUES WITH THE HANDS/MASTER CONTROLLERS DURING THE REPORTED PROBLEM. THERE WAS NO REPORTED SURGEON INJURY RESULTING FROM THIS ISSUE. THERE WAS NO RELATED ERRORS IN THE LOGS. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED IF THE SURGEON MOVED AWAY FROM SSC BETWEEN THE SHOCKS (INCREASING THE LIKELIHOOD OF STATIC ELECTRICITY) AND THE CUSTOMER DESCRIBED THE SURGEON AS SITTING BOTH TIMES AND NOT GETTING UP IN BETWEEN. THE CUSTOMER WAS PROCEEDING WITH THE CASE. FOLLOW-UP WAS PERFORMED WITH THE CUSTOMER AND THE FOLLOWING INFORMATION WAS OBTAINED FROM THE ROBOTICS COORDINATOR. THERE WAS NO INJURY OR HARM TO THE SURGEON OR THE PATIENT. THE SURGEON DESCRIBED THE SHOCKS AS TWO OCCURRENCES OF MINOR ZAPS THAT OCCURRED FOR TWO TO THREE SECONDS. THE PROCEDURE WAS COMPLETED AS PLANNED AND THE ZAPS DID NOT REOCCUR. FOLLOW-UP WAS PERFORMED WITH THE SURGEON TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO RESPONSE HAS BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104489 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-15 00886874110744

    Patients

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