BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI

    MDR report key: 4309913 · Received December 9, 2014

    Report

    Report Number
    2955842-2014-05820
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Date of Event
    October 31, 2014
    Report Date
    November 10, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    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 CONFIRMED THE REPORTED ISSUE OF THE PSM FAILING FRICTION TEST. THE PSM ALSO 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 FRICTION TEST ON THE PSM. 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
    793951 DA VINCI SI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1