BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 3430688 · Received October 25, 2013

    Report

    Report Number
    2955842-2013-04662
    Event Type
    Malfunction
    Date Received
    October 25, 2013
    Date of Event
    August 13, 2013
    Report Date
    September 30, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND SOME INSULATION WAS REMOVED AND THE METAL UNDER THE INSULATION WAS EXPOSED. THE LENGTHS OF THE SCRATCHES MEASURED APPROXIMATELY .052 - .431. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION 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 SI TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE INSULATION ON THE SHAFT OF A MONOPOLAR CAUTERY INSTRUMENT WAS PEELED OFF AFTER THE INSTRUMENT WAS REMOVED FROM THE ARM AT THE END OF A CASE. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550014 MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420142-04 S10130130 679

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR DA VINCI SI SYSTEM INSTRUMENTS & ACCESSORIES, ESU