BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 3844114 · Received June 2, 2014

    Report

    Report Number
    2955842-2014-03387
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 8, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE EXHIBITED SCRATCH MARKS EXPOSING THE SILVER MATERIAL UNDERNEATH, WITH A SMALL AREA OF THE TUBE INSULATION MISSING. NO OTHER DAMAGE WAS FOUND. THE DAMAGE TO THE INSTRUMENT FOUND DURING FAILURE ANALYSIS INVESTIGATION DOES NOT CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE DAMAGE TO THE MAIN TUBE WITH MATERIAL REMOVED COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTIONS WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SPLENECTOMY PROCEDURE, THE MONOPOLAR CAUTERY INSTRUMENT WAS NOTED TO HAVE A TEAR IN THE BLACK COATING. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. 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
    321997 MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420142-04 S10130308 826

    Patients

    Seq Age Sex Outcome Treatment
    1