BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3001799 · Received March 13, 2013

    Report

    Report Number
    2955842-2013-00808
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICAL SALES REPRESENTATIVE (CSR) FOLLOWED UP WITH INITIAL REPORTER DA VINCI COORDINATOR NURSE. SHE INDICATED THAT SOMEONE IN THE SURGICAL STAFF ACCIDENTALLY TURNED ON THE AUTO FIRE SWITCH ON THE VALLEY LAB GENERATOR. THEY WERE ABLE TO SWITCH TO A BACKUP GENERATOR TO COMPLETE THE PROSTATECTOMY PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE DA VINCI SI INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: CAUTION: INADVERTENT ELECTROSURGICAL ENERGY MAY CAUSE SERIOUS INJURY OR SURGICAL COMPLICATIONS TO THE PATIENT. IT IS IMPORTANT TO ENSURE A FULL UNDERSTANDING OF THE DA VINCI SURGICAL SYSTEM ENERGY USER INTERFACE AND USE CAUTION WHEN WORKING NEAR CRITICAL ANATOMY. AS OF (B)(4) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE FENESTRATED BIPOLAR INSTRUMENT WAS FIRING WITHOUT THE SURGEON'S INPUT. ISI TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO CHECK THE VALLEY LAB GENERATOR SETTINGS TO ENSURE THAT THE AUTO FIRE BUTTON WAS NOT TURNED ON. THE DA VINCI COORDINATOR NURSE WAS NOT ABLE TO FIND THE AUTO FIRE SETTINGS. THE CUSTOMER SWAPPED TO A BACKUP GENERATOR; THE PROSTATECTOMY PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105483 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES