BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 3133897 · Received May 29, 2013

    Report

    Report Number
    2955842-2013-01870
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 3, 2013
    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. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE BASE OF THE INSTRUMENT'S YAW PULLEY EXHIBITED BURN MARKS AND MELTED MATERIAL, INDICATING THAT AN ARCING EVENT OCCURRED. THE CONDUCTOR WIRE INSULATION DID NOT EXHIBIT DAMAGE AND THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF DOES NOT CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE ARCING DAMAGE TO THE INSTRUMENT'S YAW PULLEY FOUND DURING FAILURE ANALYSIS MAY LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PERMANENT CAUTERY SPATULA (PCS) INSTRUMENT SPARKED. THERE WERE NO MISSING 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
    234934 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10130121 868

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES