BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3843448 · Received June 2, 2014

    Report

    Report Number
    2955842-2014-03365
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 7, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS NOT ABLE TO VERIFY THE REPORTED COMPLAINT. THE INSTRUMENT WAS CHECKED FOR RECOGNITION ON AN IN-HOUSE SYSTEM AND THE INSTRUMENT WAS SUCCESSFULLY RECOGNIZED. THE POGO PINS DID NOT STICK. THE INSTRUMENT WAS DRIVEN AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FOUND TO BE FULLY FUNCTIONAL. ADDITIONAL OBSERVATION NOT REPORTED WAS INSTRUMENT'S TUBE EXTENSION HAD PAD PRINTING REMOVED. NO OTHER DAMAGE WAS FOUND. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING. 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 ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE EXTENSION TUBE PAD PRINTING REMOVAL FOUND DURING FAILURE ANALYSIS 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 MYOMECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS NOT RECOGNIZED AND WOULD NOT MOUNT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND 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
    322124 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10140115 841

    Patients

    Seq Age Sex Outcome Treatment
    1