BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3853920 · Received June 6, 2014

    Report

    Report Number
    2955842-2014-03485
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 21, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. DUE TO THE CONDITION OF THE INSTRUMENT, IT COULD NOT BE PLACED ON IN-HOUSE SYSTEM TO VERIFY A CUT TEST OR FUNCTIONALITY. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING: THE INSTRUMENT'S TUBE EXTENSION WAS BROKEN. THE TUBE EXTENSION WAS BROKEN AND MISSING A PIECE MEASURING APPROXIMATELY .204 X .248. TUBE EXTENSION ALSO HAS LIGHT MATERIAL MISSING FROM A SCRATCH GOING ACROSS THE MAIN TUBE. FAILURE ANALYSIS CONCLUDED THAT THE BROKEN DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. THERE WAS CRACKING ON THE TUBE EXTENSION WITH LIGHT PAD PRINTING REMOVAL. FAILURE ANALYSIS CONCLUDED THAT THE PAD PRINTING REMOVAL MAY HAVE BEEN LIKELY DUE TO MISHANDLING/MISUSE. 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 AND LIGHT MATERIAL MISSING FROM A SCRATCH GOING ACROSS THE MAIN TUBE 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 HYSTERECTOMY SURGICAL PROCEDURE, IT WAS NOTED THAT THE MONOPOLAR CURVED SCISSORS INSTRUMENT QUIT WORKING PART WAY THROUGH THE PROCEDURE. 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
    332179 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 N10140214 450

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR