BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC CURVED SHEARS INSERT

    MDR report key: 1221483 · Received November 3, 2008

    Report

    Report Number
    2955842-2008-01351
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 31, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT AND INSERT ACCESSORY WERE NOT 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 AND/OR INSERT ACCESSORY ARE RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TEN MINUTES INTO A DA VINCI S THYMECTOMY PROCEDURE, WHILE THE SURGEON WAS DISSECTING THE THYMUS, THE HARMONIC CURVED SHEARS (HCS) INSERT SEPARATED AND FELL INTO THE PATIENT. THE HCS INSERT WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT. THE REPLACEMENT HARMONIC CURVED SHEARS (HCS) INSERT SEPARATED AND FELL INTO THE PATIENT. THE SECOND HCS INSERT WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT. THE PROCEDURE WAS LENGTHENED SLIGHTLY DUE TO THESE EVENTS. 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 ACCESSORY GEI INTUITIVE SURGICAL, INC. 400169-06 C6341

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other HARMONIC CURVED SHEARS INSTUMENT| DA VINCI SURGICAL SYSTEM| AN ELECTROSURGICAL UNIT| ACCESSORIES