BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4295409 · Received December 3, 2014

    Report

    Report Number
    2955842-2014-05783
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PSM WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. FAILURE ANALYSIS INVESTIGATION FOUND THAT THE PSM FAILED THE WEIGHTED BRAKE DROP TEST. THE PSM PASSED SLOW SWEEP TESTING. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT SIDE MANIPULATOR ARM FAILING WEIGHTED BRAKE DROP TESTING DURING FAILURE ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, AN ERROR 25580 PRESENTED ON THE PATIENT SIDE MANIPULATOR (PSM). THE CUSTOMER PRESSED THE OVERWRITE BUTTON, BUT THE ERROR OCCURRED AGAIN AND THE SURGEON DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781828 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1