BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORSINSTRUMENT

    MDR report key: 2991454 · Received March 6, 2013

    Report

    Report Number
    2955842-2013-00749
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 6, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT. ENGINEERING WAS UNABLE TO PERFORM THE CUT TEST DUE TO A BROKEN GRIP CABLE. ENGINEERING FOUND A BROKEN GRIP CABLE. THE ONE GRIP CLOSE CABLE WAS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT STUCK OUT AT THE WRIST. THE OTHER CABLES AT WRIST WERE NOT DAMAGED. THE ELECTRICAL CONTINUITY TESTING PASSED. ADDITIONALLY, ENGINEERING FOUND AN INDENTATION ON THE EDGE OF THE DISTAL PULLEY. THE LAST FINDING WAS PRINT REMOVED FROM EXTENSION TUBE. THE PART OF THE PRINT WAS REMOVED FROM THE EXTENSION TUBE MEASURED ROUGHLY ABOUT 0.356 X 0.188. ENGINEERING CONCLUDED THE DAMAGE WAS MOST LIKELY DUE TO IMPROPER CLEANING. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: WARNING: READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW INSTRUCTIONS MAY CAUSE IMPROPER FUNCTIONING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI SI HYSTERECTOMY PROCEDURE THAT THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS NOTED TO BE DULL. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95154 MONOPOLAR CURVED SCISSORSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M11121205 340

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES