BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 3909125 · Received July 2, 2014

    Report

    Report Number
    2955842-2014-04053
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 12, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS AND ABRASIONS. THE MAIN TUBE INSULATION WAS SCRATCHED AND SOME OF THE INSULATION WAS REMOVED AT THE DISTAL END. THE SCRATCHES MEASURED APPROXIMATELY .022 - .096 IN LENGTH. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE MAIN TUBE IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI SURGICAL PROCEDURE, IT WAS NOTED THAT THE DISTAL INSULATION ON THE MONOPOLAR CAUTERY INSTRUMENT WAS TORN. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388134 MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420142-04 S10120907 275

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR