BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4434750 · Received January 20, 2015

    Report

    Report Number
    2955842-2015-00125
    Event Type
    Malfunction
    Date Received
    January 20, 2015
    Date of Event
    December 16, 2014
    Report Date
    December 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    2955842-020312-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SIDE MANIPULATOR (PSM) ARM WAS RETURNED TO INTUITIVE SURGICAL, INC (ISI) FOR EVALUATION. FAILURE ANALYSIS INVESTIGATION FOUND THE PSM FAILED THE SLOW SWEEP FRICTION TEST. INTUITIVE SURGICAL, INC. (ISI) HAS CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE AND DID NOT FIND ANY NON-CONFORMANCES THAT WOULD AFFECT ANY MATERIAL OF THE FINAL PRODUCT AND/OR THE QUALITY OR PERFORMANCE OF THE INSTRUMENT USED DURING THIS REPORTED EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE PSM ARM FAILING THE SLOW SWEEP FRICTION TEST DURING FAILURE ANALYSIS. ALTHOUGH THIS WAS FOUND DURING A REVIEW OF SITE'S ERROR LOGS AND NO PATIENT INVOLVEMENT OCCURRED, IF THIS MALFUNCTION WERE TO RECUR IT COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS INITIALLY REPORTED TO INTUITIVE SURGICAL, INC. (ISI) FOR PATIENT SIDE MANIPULATOR (PSM) NOT HOMING CORRECTLY. AN ISI REPRESENTATIVE REVIEWED THE ERROR LOGS AND FOUND REPEATED ERRORS ON THE PSM 2. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE PSM WAS REPLACED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ADVERSE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45494 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1