BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 15884229 · Received November 30, 2022

    Report

    Report Number
    2955842-2022-15613
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Date of Event
    October 31, 2022
    Report Date
    October 31, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    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. BASED ON FIELD EVALUATION, THE FSE REPLACED THE PATIENT SIDE MANIPULATOR 2 (PSM2) TO RESOLVE THE ISSUE. ISI RECEIVED THE PATIENT SIDE MANIPULATOR (PSM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. THE FAILURE ANALYSIS IDENTIFIED DAMAGE TO THE INSERTION FLAT FLEX CABLES (FFCS) WITHIN THE ARM, AND THE ERROR WAS REPLICATED. ADDITIONALLY, COSMETIC DEFECTS WERE FOUND ON THE ARM. AS A FIX, THE INSERTION FLAT FLEX CABLES (FFCS) WILL BE REPLACED. THE COMPLAINT REGARDING THE REPEATED RECOVERABLE ERRORS WERE CONFIRMED BASED ON THE FIELD EVALUATION AND THE PROBABLE ROOT CAUSE OF THIS REPORTED ISSUE IS ATTRIBUTED TO THE COMPONENT FAILURE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY THE TECHNICAL SUPPORT ENGINEER (TSE). INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 25807 - POSSIBLE SHORT IN THE MOTOR OR AMPLIFIER CIRCUITS. PER THE TSE REVIEW, THIS ERROR MESSAGE POINTS TO A BOARD WITHIN THE PATIENT SIDE MANIPULATOR 2 (PSM2). IMAGES OF THE ERRORS OBSERVED WERE PROVIDED BY THE CUSTOMER. REVIEW OF THE PROVIDED IMAGES IS CONSISTENT WITH THE ERROR MESSAGE REPORTED IN THE COMPLAINT. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER WAS NOT ABLE TO FULLY RESOLVE THE ERROR MESSAGES AFTER THE START OF THE PROCEDURE. FURTHERMORE, COMPLAINT INVESTIGATION CONFIRMED THAT THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PATIENT SIDE MANIPULATOR 2 (PSM2) TO RESOLVE THE ISSUE. 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. SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION/ABORTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED REPEATED RECOVERABLE FAULTS ON ARM 2; SPECIFICALLY, ERROR 25807 WAS OBSERVED. THE CUSTOMER WAS ABLE TO RECOVER THE SYSTEM AND CONTINUED WITH THE CASE AS PLANNED WITH NO PATIENT INJURY REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED-UP WITH THE CUSTOMER AND CONFIRMED THAT THE PROCEDURE WAS COMPLETED WITHOUT DISABLING OR ABANDONING THE PATIENT SIDE MANIPULATOR (PSM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729311 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-34 N/A 00886874114605

    Patients

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