BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT SHEARS (TM) (MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3112267 · Received May 14, 2013

    Report

    Report Number
    2955842-2013-01657
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE REPORTED FAILURE MODE. THE MCS INSTRUMENT WAS PLACED ON IN-HOUSE DA VINCI ROBOT SYSTEM AND IT WAS ABLE TO ADVANCE PASS THE CANNULA OPENING WITH NO TROUBLE. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS MAIN TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED DIFFICULTY WHILE ADVANCING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212619 HOT SHEARS (TM) (MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10121013 169

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES