BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE NEVERTOUCH

    MDR report key: 2861797 · Received November 7, 2012

    Report

    Report Number
    1319211-2012-00236
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVAL WAS A VENA CURE EVLT NEVER TOUCH FIBER. IT WAS NOTED THAT THE FIBER APPEARED TO BE USED AND VISUAL INSPECTION NOTED NO ABNORMALITIES. THE SAMPLE WAS POWERED TESTED ON A LASER. DURING POWER TESTING THE TEMPERATURE OF THE FIBER WAS MEASURED AT REST (72.5 F) AND DURING (75 F). NO SIGNIFICANT CHANGE IN TEMPERATURE WAS NOTED. THE FIBER MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE CUSTOMER'S COMPLAINT DESCRIPTION CANNOT BE CONFIRMED. 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. A REVIEW OF THE HARDWARE SERVICE RECORDS FOR THIS ACCOUNT'S VENA CURE 1470 LASER GENERATOR (SERIAL NUMBER (B)(4)) NOTED THAT THE UNIT WAS RETURNED TO ANGIODYNAMICS AFTER THE REPORTED PRODUCT FAILURE COMPLAINT FOR INSPECTION. THE UNIT WAS TESTED AND WAS FOUND TO HAVE MET THE ACCEPTANCE CRITERIA. THE ROOT CAUSE OF THE REPORTED COMPLAINT DESCRIPTION IS UNK AS THE RETURNED DEVICE FUNCTIONED AS INTENDED. PRIOR TO SHIPPING, THE LASER FIBERS RECEIVE TO 100% INSPECTIONS AND ONE AQL INSPECTION IN WHICH THE POWER OUTPUT IS CHECKED FOR EACH FIBER. IN ADDITION, THE SMA END OF EACH FIBER IS VISUALLY INSPECTED TO DETECT THIS FAILURE MODE. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, A FEMALE PT OF UNK AGE PRESENTED FOR AN ENDOVENOUS LASER TREATMENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE ENTIRE FIBER BECAME HOT WHEN THE LASER WAS FIRED AFTER ONLY A FEW SECONDS. THE LASER GENERATOR WAS TURNED OFF, THE FIBER WAS REMOVED FROM THE PT AND REPLACED WITH A NEW SECOND FIBER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE NEWLY REPLACED. DEVICE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PT. THE REPORTED FAILED DEVICE WAS RETURNED TO MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENACURE NEVERTOUCH ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS 577930

    Patients

    Seq Age Sex Outcome Treatment
    1