BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3863725 · Received June 10, 2014

    Report

    Report Number
    2955842-2014-03537
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 29, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT OF MONOPOLAR CURVED SCISSORS WOULD NOT CUT. THERE WAS NO TROUBLE FOUND. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE DA VINCI SYSTEM FOR A CUT TEST. THE SCISSORS CUT CLEANLY THROUGH 0.006 OF LATEX. THE BLADE EDGES WERE NOT DAMAGED; HOWEVER, IT EXHIBITED WEAR. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL MISSING. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE VARIOUS SCRATCH MARKS ON THE MAIN TUBE WITH LIGHT MATERIAL MISSING FOUND DURING FAILURE ANALYSIS IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MONOPOLAR CURVED SCISSORS INSTRUMENT WOULD NOT CUT BECAUSE THEY WERE NOT SHARP ENOUGH. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340547 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10140215 112

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR