BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC CURVED SHEARS INSERT

    MDR report key: 1903773 · Received November 20, 2010

    Report

    Report Number
    2955842-2010-00503
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 19, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K042855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARMONIC CURVED INSERT ACCESSORY WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE CUSTOMER REPORTED COMPLAINT AND FOUND THE INSERT TO BE RETURNED WITH A MISSING CLAMP ARM. THE CLAMP ARM CONNECTION JOINT WAS DAMAGED AND SIGNS OF OVER-EXTENSION OF THE CLAMP ARM WERE OBSERVED. NO OTHER DAMAGE WAS 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 HYSTERECTOMY PROCEDURE, A PIECE FROM THE HARMONIC CURVED SHEARS INSERT, INSTALLED ON THE HARMONIC CURVED SHEARS INSTRUMENT, BROKE OFF AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. 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 ACCESSORY NAY INTUITIVE SURGICAL,INC. 400169-07

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM, INSTRUMENT AND ESU.