BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 1844137 · Received September 24, 2010

    Report

    Report Number
    2955842-2010-00402
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K002489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST-EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. INTUITIVE SURGICAL 8MM ENDOWRIST INSTRUMENTS FOR USE ON THE DA VINCI S SURGICAL SYSTEM HAVE BEEN TESTED FOR MATERIAL BIOCOMPATIBILITY. THE MATERIALS IN THESE INSTRUMENTS HAVE BEEN TESTED FOR BIOCOMPATIBILITY IN ACCORDANCE WITH (B)(4) FOR THEIR INTENDED USE (BLOOD PATH, INDIRECT (4.2.3.A) AND LIMITED EXPOSURE (4.3.A)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S MYOMECTOMY PROCEDURE THE PERMANENT CAUTERY HOOK INSTRUMENT BROKE AND PIECES FELL INTO THE PATIENT. NOT ALL PIECES WERE BELIEVED TO HAVE BEEN RETRIEVED. THE PLANNED SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR DA VINCI S SYSTEM, ACCESSORIES & ESU