BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE CURVED SHEARS INSTRUMENT

    MDR report key: 3151284 · Received June 7, 2013

    Report

    Report Number
    2955842-2013-02040
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 15, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT WITH THE FOLLOWING CLARIFICATION: THE INSERT FAILED A SELF-TEST ON THE GENERATOR. A FUNCTIONAL ENERGY TEST WAS PERFORMED USING A HARMONIC GENERATOR AND HANDPIECE. THE INSERT FAILED A SELF-TEST, CAUSING THE GENERATOR TO PRODUCE AN INSTRUMENT ERROR MESSAGE. A HIGH PITCHED NOISE WAS HEARD DURING THE SELF TEST. THE INSERT WAS VISUALLY INSPECTED UNDER MAGNIFICATION AND A HAIRLINE CRACK WAS FOUND ON THE BLADE. THE CRACK WAS LOCATED .400 BELOW THE DISTAL TIP. A GOUGE AND SCRATCH WAS ALSO OBSERVED ON THE BLADE EDGE IN THE SAME AREA AS THE CRACK. ENGINEERING CONCLUDED BASED ON LOCATION OF DAMAGE, THE GOUGE WAS LIKELY CAUSED BY MISHANDLING/MISUSE. NO OTHER DAMAGE FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS O 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 MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION 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 SI MYOMECTOMY PROCEDURE THE HARMONIC ACE CURVED SHEARS INSERT WORKED FOR ABOUT THE 20 MINUTES AND THEN THE GENERATOR WOULD NOT ENGAGED. NOTHING REPORTEDLY FELL INTO A PATIENT. 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
    253311 HARMONIC ACE CURVED SHEARS INSTRUMENT ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400272-02 M10121022

    Patients

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