BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC CURVED SHEARS INSERT

    MDR report key: 2080766 · Received May 6, 2011

    Report

    Report Number
    2955842-2011-00140
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K042855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE INSERT WAS RETURNED AND EVALUATED, BUT NOT THE CLAMP ARM. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE INSTRUMENT CLAMP ARM MISSING FROM THE DISTAL END. CLAMP ARM PINS WERE BENT BACKWARDS. THE CAUSE OF THE USER DAMAGE WAS LIKELY DUE TO THE USER MISHANDLING AND/OR OVER EXTENSION OF THE ARM. THERE WAS NO OTHER DAMAGE FOUND. 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 A DA VINCI S SIGMOID COLECTOMY, AN UNIDENTIFIED ITEM FROM THE HARMONIC CURVED SHEARS INSERT INSTRUMENT FELL INTO THE PATIENT AND WAS IMMEDIATELY RETRIEVED. THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED TO DATE. 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 NAY INTUITIVE SURGICAL,INC. 400169-07 M10100705

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR DA VINCI S SYSTEM, INSTRUMENTS, ACCESSORIES