BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3913958 · Received July 3, 2014

    Report

    Report Number
    2955842-2014-04085
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 AND DRIVEN AND PASSED RECOGNITION AND ENGAGEMENT TESTING. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE SCISSORS OPENED AND CLOSED PROPERLY. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S TUBE EXTENSION HAD PAD PRINTING REMOVED. THE PAD PRINTING HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL MISSING. THE SCRATCHED AREA MEASURED APPROXIMATELY .143 X .362. FAILURE ANALYSIS CONCLUDED THAT THE PAD PRINTING REMOVAL WAS LIKELY 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 MONOPOLAR CURVED SCISSORS INSTRUMENT'S JAW WAS NOT ROTATING WELL. 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
    389757 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10131212 761

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR