BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALON ELECTROSURGICAL DEVICE, 15CM

    MDR report key: 4304431 · Received November 20, 2014

    Report

    Report Number
    1056436-2014-00068
    Event Type
    Malfunction
    Date Received
    November 20, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 13, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    K010060
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014 BY THE USER FACILITY IR SUPERVISOR, "REF 700-102847 LOT 4799104: THE COZXIAL (COAXIAL) SHEATH THAT THE TINES RETRACT INTO BECAME SEPARATED AND DURING TRACT ABLATION. THE CENTER NEEDLE WITH COAXIAL PROTION (PORTION) REMAINED INSIDE THE PATIENT POST TRACT ABLATION. THE PROBE WAS ABLE TO BE REMOVED SAFELY FROM THE PATIENT. NO HARM OR SERIOUS INJURY REPORTED FOR THIS PATIENT FOR THIS EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755300 TALON ELECTROSURGICAL DEVICE, 15CM ELECTROSURGICAL DEVICE GEI ANGIODYNAMICS 4799104

    Patients

    Seq Age Sex Outcome Treatment
    1