BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3749610 · Received April 14, 2014

    Report

    Report Number
    2955842-2014-02205
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 20, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE SCISSORS CUT CLEANLY THROUGH .006 LATEX UPON PLACING THE INSTRUMENT ON AN IN-HOUSE SYSTEM. THE LATEX DID NOT GET SNAGGED AT THE SCISSOR TIPS. THE BLADE EDGES WERE NOT DAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE HAD A SCRATCH MARK WITH LIGHT MATERIAL REMOVAL. THE SCRATCH MEASURED APPROXIMATELY .182 - .065 IN LENGTH AND WAS NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE ADDITIONAL OBSERVATION OF THE MAIN TUBE SCRATCH WITH MISSING MATERIAL COULD 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 SALPINGECTOMY PROCEDURE, IMMEDIATELY UPON USING THE MONOPOLAR CURVED SCISSORS INSTRUMENT, THE SURGEON COMPLAINED THEY WERE DULL, FINISHED CASE WITH THESE SCISSORS. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. NOTHING REPORTEDLY FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226488 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10130809 565

    Patients

    Seq Age Sex Outcome Treatment
    1