BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOK INSTRUMENT

    MDR report key: 595601 · Received April 20, 2005

    Report

    Report Number
    2955842-2005-00030
    Event Type
    Malfunction
    Date Received
    April 20, 2005
    Date of Event
    March 11, 2005
    Report Date
    March 11, 2005
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE PERMANENT CAUTERY HOOK INSTRUMENT MALFUNCTIONED AND BECAME STUCK IN A RIGHT ANGLE. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY HOK INSTRUMENT ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL, INC. 400126-08 1012041 14

    Patients

    Seq Age Sex Outcome Treatment
    1 *