BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARBURST XL, 9 ARRAY, 3-5CM, 15CM

    MDR report key: 3831903 · Received March 6, 2014

    Report

    Report Number
    1056436-2014-00017
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    December 14, 2013
    Report Date
    February 27, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    K992693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING LOT FOR ANY DEVIATIONS RELATED TO REPORTED DEFECT AND THE REVIEW CONFIRMED THAT THE PACKAGING LOT AND ALL COMPONENT LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATION. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS 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 DISTRIBUTOR IN (B)(6), "FOR THE TARGET 4 CM ABLATION, THE DOCTOR FOUND THAT THE ABLATION WAS ALREADY TO 6 CM WHEN THE XL ELECTRODE WAS JUST DEPLOYED TO 3.8 CM". NO OTHER HARM OR INJURY WERE REPORTED DUE TO THIS PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134523 STARBURST XL, 9 ARRAY, 3-5CM, 15CM ELECTROSURGICAL DEVICE GEI ANGIODYNAMICS 599699

    Patients

    Seq Age Sex Outcome Treatment
    1