BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 3052845 · Received April 11, 2013

    Report

    Report Number
    2955842-2013-01194
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE DAMAGED INSULATION ON THE INSTRUMENT. ENGINEERING FOUND THAT THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS AND GOUGE MARKS WITH LIGHT MATERIAL REMOVAL. ENGINEERING CONCLUDED THAT THE DAMAGE WAS MOST LIKELY CAUSED BY MISHANDLING (EXCESS FORCE CONTACT ON THE MAIN TUBE SURFACE). 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 REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    PRIOR TO STARTING A DA VINCI SI PROCEDURE, THE USER FACILITY REPORTEDLY IDENTIFIED DAMAGED INSULATION ON A MONOPOLAR CAUTERY INSTRUMENT. THE INSTRUMENT WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156720 MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420142-04 S10110615 565

    Patients

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