BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3813263 · Received May 15, 2014

    Report

    Report Number
    2955842-2014-03001
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 21, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED ON AN IN HOUSE SYSTEM FOR A LATEX CUT TEST. THE SCISSORS CUT CLEANLY THROUGH .006 LATEX. THE BLADE EDGES WERE NOT DAMAGED. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. THE FLUSH TUBE WAS NOT KINKED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENTS TUBE EXTENSION PAD PRINTING WAS REMOVED. FAILURE ANALYSIS CONCLUDED THAT THE PAD PRINTING REMOVAL WAS DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST® INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE PAD PRINTING REMOVAL 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 NOTED THAT THE BLADES WERE DULL ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289406 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10140108 532

    Patients

    Seq Age Sex Outcome Treatment
    1