BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4850756 · Received June 17, 2015

    Report

    Report Number
    2955842-2015-00915
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 28, 2015
    Report Date
    June 16, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    2955842-11-11-2013-013-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PSM ARM WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. FAILURE ANALYSIS INVESTIGATION FOUND THAT THE ARM FAILED IN-HOUSE SLOW SWEEP TESTING. THE AXIS-2 BRAKE WAS REPLACED AND THE ARM WAS UPGRADED. THE COMPLAINT IS BEING REPORTED DUE TO THE PSM FAILING SLOW SWEEP TESTING DURING FAILURE ANALYSIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DA VINCI SI SURGICAL SYSTEM LOGS PRODUCED AN ERROR MESSAGE ON PATIENT SIDE MANIPULATOR (PSM) ARM 2. THE PSM IS AN INSTRUMENT ARM WHICH IS LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. WHEN THIS ISSUE OCCURRED, THERE WAS NO PATIENT INVOLVEMENT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) REPLACED THE ARM AND HAD NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392998 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1