BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 4309934 · Received December 9, 2014

    Report

    Report Number
    2955842-2014-05821
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 17, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE PSM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE INVESTIGATION. FAILURE ANALYSIS FOUND THE PSM HAD FAILED THE WEIGHTED BRAKE DROP TEST.

    Description of Event or Problem · 1

    DURING A PREVENTATIVE MAINTENANCE OF A DA VINCI SI SURGICAL SYSTEM BY AN INTUITIVE SURGICAL INC. REPRESENTATIVE FOUND THE PATIENT SIDE MANIPULATOR (PSM) HAD FAILED THE BRAKE TEST. THE PSM WAS REPLACED. THE PSM IS AN INSTRUMENT ARM WHICH IS LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795917 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1