BEUDAMED
    FDA Adverse Event Other Summary report: N

    TALON ELECTROSURGICAL DEVICE

    MDR report key: 1215653 · Received October 20, 2008

    Report

    Report Number
    1056436-2006-00074
    Event Type
    Other
    Date Received
    October 20, 2008
    Date of Event
    April 13, 2006
    Report Date
    October 9, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    Removal / Correction Number
    Z-0887-06 AND Z-0888-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER BECAUSE THE PT HAD A TRANSMISSABLE DISEASE, HEP. C. A VIDEO TAPE OF THE DEVICE WAS REVIEWED. THE VIDEO CLIP SHOWS THAT THE NEEDLE HAD THE DESIGN OF A TALON BUT MARKINGS OF AN XLIE. THE COMPLAINT WAS CONFIRMED BY THE VIDEO CLIP. A CORRECTIVE ACTION WAS OPENED TO CORRECT THIS ISSUE AND A FIELD ACTION WAS IMPLEMENTED.

    Description of Event or Problem · 1

    DURING PROCEDURE, IT WAS NOTICED THAT THE TALON DEVICE PLACED IN THE PT, HAD AN XLIE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALON ELECTROSURGICAL DEVICE ELECTROSURGICAL DEVICE GEI ANGIODYNAMICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other