BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 16490525 · Received March 6, 2023

    Report

    Report Number
    2955842-2023-11094
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    February 7, 2023
    Report Date
    February 7, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE TO THE BLUE FIBER CABLE, 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 CONFIRMED THE REPORTED PROBLEM AND NOTED ERROR 23 IN THE LOG FILES INDICATING COMMUNICATION ERRORS. THE BLUE FIBER CABLE WAS REPLACED TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PART [PN 380989] INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION. THE COMPLAINT REGARDING PHYSICAL DAMAGE TO THE BLUE FIBER CABLE WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO LAP AFTER THE START OF THE PROCEDURE DUE TO DAMAGE TO THE BLUE FIBER COMMUNICATIONS CABLE. 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 RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER PHYSICALLY DAMAGED A BLUE FIBER CABLE WHILE DOCKING. A FIELD SERVICE ENGINEER ADVISED CONNECTING A BACKUP BLUE FIBER CABLE WHICH DID NOT WORK. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC TECHNIQUES WITH NO INJURY REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CONNECTOR WAS TRIPPED OVER AND PULLED OUT OF THE SURGEON SIDE CONSOLE (SSC). VISIBLE DAMAGE WAS OBSERVED TO THE END OF THE CORD WHERE IT WAS FORCIBLY PULLED OUT OF THE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574318 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-09 N/A 00886874110874

    Patients

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