BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15765083 · Received November 9, 2022

    Report

    Report Number
    2955842-2022-15145
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 10, 2022
    Report Date
    October 10, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 COMPLAINT. FSE COULD NOT REPRODUCE NOR CONFIRM THE REPORTED ISSUE. NO PARTS WERE REPLACED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE SYSTEM WAS TESTED TO ORIGINAL EQUIPMENT MANUFACTURER SPECIFICATIONS. A LOG REVIEW CONFIRMED THE SIMPLE PROSTATECTOMY PROCEDURE OCCURRED ON (B)(6) 2022 ON SYSTEM SK4837. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT PATIENT SIDE CART UNIVERSAL SURGICAL MANIPULATORS MOVED IN AN UNEXPECTED WAY. UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE 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 PROSTATECTOMY-SIMPLE SURGICAL PROCEDURE, THE PATIENT SIDE CART (PSC) MOVEMENT WAS IN INCOHERENT DIRECTION. THE CALLER (NURSE), HOWEVER, CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AFTER THE SURGERY. THE CALLER SPECIFIED THAT WHEN THE SURGEON MOVED TO RIGHT, THE ARM CONTROLLED MOVED DOWN. AFTER THE ISSUE OCCURRED, THE OPERATING ROOM (OR) TEAM POWER CYCLED THE SYSTEM, AND THE ISSUE WAS RESOLVED. TSE REVIEWED THE LOGS AND FOUND NOTHING RELEVANT. TSE INSTRUCTED THE NURSE TO RESEAT THE LOCAL AREA NETWORK (LAN) CABLE, BECAUSE THE LOGS SEEMED TO BE INCOMPLETE, HOWEVER, THE NURSE INDICATED THAT THE VISION SIDE CART (VSC) WAS BEING USED WITH THE ENDOSCOPE FOR MANUAL EXPLORATION. SYSTEM WAS READY FOR USE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2431846 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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