BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI S SURIGICAL SYSTEM

    MDR report key: 4535370 · Received February 23, 2015

    Report

    Report Number
    2955842-2015-00333
    Event Type
    Malfunction
    Date Received
    February 23, 2015
    Date of Event
    January 29, 2015
    Report Date
    February 12, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Removal / Correction Number
    2955842-020312-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PSM WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS INVESTIGATION FOUND THE PSM FAILED THE WEIGHTED BRAKE DROP TEST. INTUITIVE SURGICAL, INC. (ISI) HAS CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS PSM AND DID NOT FIND ANY NON-CONFORMANCES THAT WOULD AFFECT ANY MATERIAL OF THE FINAL PRODUCT AND/OR THE QUALITY OR PERFORMANCE OF THE PSM USED DURING THIS REPORTED EVENT. THE COMPLAINT IS BEING REPORTED DUE TO THE PSM FAILING THE WEIGHTED BRAKE DROP TEST DURING FAILURE ANALYSIS INVESTIGATION. ALTHOUGH THIS FAILURE WAS FOUND DURING FAILURE ANALYSIS, IF THIS MALFUNCTION WERE TO RECUR IT COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI PROSTATECTOMY SURGICAL PROCEDURE THAT THE PATIENT SIDE MANIPULATOR (PSM) CONTINUOUSLY FAULTED WITH AN ERROR MESSAGE. THE PSM IS AN INSTRUMENT ARM WHICH IS LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE PSM WAS REPLACED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT OR ADVERSE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125449 DA VINCI S SURIGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1