BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 5347602 · Received January 6, 2016

    Report

    Report Number
    2955842-2016-00005
    Event Type
    Malfunction
    Date Received
    January 6, 2016
    Date of Event
    November 9, 2015
    Report Date
    December 9, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PSM ARM WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. FAILURE ANALYSIS INVESTIGATION WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED FAILURE MODE. FUNCTIONAL TESTING OF THE PSM ON AN IN-HOUSE IS3000 SYSTEM FOUND THAT AXIS 2 BEHAVED IN A STIFF MANNER, THERE WAS A LOT OF RESISTANCE AND SYSTEM ERROR CODE 23007 WAS GENERATED INDICATING THAT THERE WAS AN ISSUE WITH THE MOTOR OR SENSOR OR THAT THE PSM WAS BEING RESTRICTED FROM MOVING BY INTERNAL OR EXTERNAL FORCES. THE PSM ALSO FAILED SLOW SWEEP TESTING. THIS COMPLAINT IS BEING REPORTED DUE TO THE PSM ARM FAILING THE SLOW SWEEP TEST DURING INTERNAL FAILURE ANALYSIS INVESTIGATION. ALTHOUGH THERE WAS NO PATIENT INVOLVEMENT, IF THIS MALFUNCTION WERE TO RECUR IT COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED CHOLECYSTECTOMY PROCEDURE, PATIENT SIDE MANIPULATOR (PSM) ARM 2 ON THE PATIENT SIDE CART (PSM) BEHAVED IN A RESTRICTED MANNER. THE PLANNED SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO REPORT OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY. THE INVESTIGATION PERFORMED BY THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED FAILURE MODE. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6388 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P9B

    Patients

    Seq Age Sex Outcome Treatment
    1