BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4847671 · Received June 16, 2015

    Report

    Report Number
    2955842-2015-00908
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    May 3, 2015
    Report Date
    May 21, 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 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.

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE, IT WAS REPORTED BY THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST THAT THE PATIENT SIDE MANIPULATOR (PSM) 2 FAILED THE SLOWSWEEP TEST. THIS FAILURE WAS FOUND DURING PREVENTATIVE MAINTENANCE AND HAD NO PATIENT INVOLVEMENT, HOWEVER IF THIS MALFUNCTION WERE TO RECUR DURING A SURGICAL PROCEDURE, IT COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. THE PSM IS AN INSTRUMENT ARM WHICH IS LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392126 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P9

    Patients

    Seq Age Sex Outcome Treatment
    1