BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC CURVED SHEARS INSERTACCESSORY

    MDR report key: 1860753 · Received October 7, 2010

    Report

    Report Number
    2955842-2010-00426
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 9, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K042855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERT ACCESSORY HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. PER THE INFORMATION PROVIDED IN THE SITE'S (B)(4), THE BROKEN PIECES FROM THE INSERT ACCESSORY WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S THYMECTOMY PROCEDURE, THE TIP OF THE INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. ON (B)(6) 2010, ISI RECEIVED MEDWATCH (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: DURING A ROBOTIC THYMECTOMY PROCEDURE, WHILE USING AN INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSERT IN THE DA VINCI ROBOT-S, ONE PORTION OF THE SHEAR SNAPPED OFF INTO THE THORACIC CAVITY, RENDERING THE EQUIPMENT UNUSABLE. MD WAS ABLE TO RETRIEVE 2 SMALL PIECES FROM THE SHEARS. THE EQUIPMENT WAS REMOVED FROM THE TABLE, REPORTED TO THE INTUITIVE REP, CENTRAL STERILE SUPPLY, AND A CHEST X-RAY WAS TAKEN UPON COMPLETION; NO OBJECTS SEEN IN PATIENT BY CHEST FILMS. PT APPEARS TO NOT HAVE ANY HARM FROM THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR DA VINCI S SYSTEM, HCS INSTRMNT, ACCESSORIES & ES