BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 2990328 · Received March 5, 2013

    Report

    Report Number
    2955842-2013-00735
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    December 31, 2012
    Report Date
    February 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE DISTAL YAW PULLEY WAS MISSING A 0.0845 PIECE FROM THE CERAMIC INSULATION WHICH IS LOCATED CLOSE TO GRIP TIP. NO SIGNS OF CHAR ON TIP WERE OBSERVED. INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. NO OTHER DAMAGE WAS FOUND. 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. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CLEANING AND STERILIZATION, THE CUSTOMER NOTED CRACKED INSULATION ON THE PERMANENT CAUTERY SPATULA INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94079 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10120117 285

    Patients

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