BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC CURVED SHEARS INSERT

    MDR report key: 2803181 · Received October 24, 2012

    Report

    Report Number
    2955842-2012-00637
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K042855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT THE TEFLON PAD OF THE HARMONIC INSERT SLIPS UP AND DOWN EASILY. THE TEFLON PAD IS OFF TRACK FROM ITS MATED SLOT, MOST LIKELY RESULTING IN THE FREE MOVEMENT. NO OTHER DAMAGE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, WHILE THE HARMONIC CURVED SHEARS INSTRUMENT WAS USED TO GRASP THE TISSUE, THE WHITE COLORED PROTECTOR SLID OUT BACKWARD. FURTHERMORE, THE LOCATION OF THE WHITE PART (PROTECTOR) WAS OUT OF NORMAL RANGE. IT WAS ALSO NOTED THAT THE PROTECTOR WAS SHAKING UP AND DOWN. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC CURVED SHEARS INSERT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 400169-07 M10120419

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI S SYSTEM INSTRUMENTS AND ACCESSORIES