BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 3150789 · Received June 6, 2013

    Report

    Report Number
    2955842-2013-02022
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT THROUGH THE PRODUCT NOTIFICATION, THE CUSTOMER HAD TAKEN INITIATIVE TO INSPECT THE ITEM THROUGH A HIGH MAG RESOLUTION AND HAD IDENTIFIED A MICRO-CRACK. THE MAIN TUBE HAD SIGNS OF ABRASION/WEAR THAT EXHIBITED DAMAGE TO THE INSULATION BUT NO MICRO-CRACKS WERE FOUND. TWO HAIRLINE SCRATCHES AND ONE SMALL CIRCULAR HOLE FOUND NEAR THE DISTAL END. NO MATERIALS WERE REMOVED OR FOUND MISSING. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    THROUGH THE PRODUCT NOTIFICATION, THE CUSTOMER HAD TAKEN INITIATIVE TO INSPECT THE MONOPOLAR CAUTERY INSTRUMENT THROUGH A HIGH MAG RESOLUTION AND HAD IDENTIFIED A MICRO CRACK. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250249 MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420142-04 S10121130 046

    Patients

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