BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVLT OPS

    MDR report key: 2841362 · Received October 23, 2012

    Report

    Report Number
    1319211-2012-00227
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. TO DATE, THE DEVICE HAS YET TO BE RETURNED. ATTEMPTS ARE BEING MADE TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER TREATMENT. DURING INSERTION INTO THE SHEATH, THE TIP OF THE FIBER BROKE AT APPROXIMATELY 3.5CM FROM THE TOP. THE ENDOVENOUS LASER WAS REPLACED WITH ANOTHER NEW OF THE SAME DEVICE AND PROCEDURE SUCCESSFULLY COMPLETED WITHOUT COMPLICATION. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT DUE TO THIS PRODUCT PROBLEM. IT WAS REPORTED THAT THE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVLT OPS ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS 006010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN