BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARBURST TALON SEMI-FLEX

    MDR report key: 3872742 · Received May 15, 2014

    Report

    Report Number
    1056436-2014-00031
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 7, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    K010060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO THE ROOT CAUSE OF THE INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION AND ANY FOLLOW UP INFO WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014 BY THE INTERNATIONAL DISTRIBUTOR, "TWO ELECTRODES OF STARBURST TALON HAVE BEEN BROKEN DURING PROCEDURE, ONE OF THE BROKEN ELECTRODES WAS TAKEN OUT THROUGH SURGERY". PROCEDURE COMPLETED WITH ANOTHER SAME DEVICE AND NO HARM OR INJURY WAS REPORTED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289661 STARBURST TALON SEMI-FLEX ELECTROSURGICAL PROBE GEI ANGIODYNAMICS 607566

    Patients

    Seq Age Sex Outcome Treatment
    1 Other