BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE NEVERTOUCH

    MDR report key: 3974859 · Received June 11, 2014

    Report

    Report Number
    1319211-2014-00087
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVALUATION WAS A NEVERTOUCH FIBER. A VISUAL REVIEW OF THE FIBER NOTED THAT THE GRIPPER IS FRACTURED. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF A FIBER FRACTURING IS CONFIRMED. THE ROOT CAUSE FOR THE REPORTED COMPLAINT IS MOST LIKELY THE USER OVER TIGHTENING THE FIBER ON THE GENERATOR CAUSING STRESS ON THE GRIPPER AND LEADING TO THE MATERIAL RIPPING AND THE INTERNAL FIBER FRACTURING. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. PRIOR TO SHIPPING, THE LASER FIBER RECEIVED TWO 100% VISUAL INSPECTIONS OF THE GRIPPER TO ENSURE IT IS SECURE AND ONE (B)(4) INSPECTION. THE LASER FIBERS ALSO RECEIVE TWO 100% INSPECTIONS AND ONE (B)(4) INSPECTION IN WHICH THE FIBER IS CONNECTED TO A LASER GENERATOR AND THE POWER OUTPUT IS CHECK FOR EACH FIBER. 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 (B)(6) 2014, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. DURING PREP, WHEN THE FIBER WAS CONNECTED TO THE LASER UNIT, THE GRIPPER OF THE FIBER FRACTURED. THE FIBER INSIDE OF THE GRIPPER APPEARED TO BE BURNT. THE DEFECTIVE DEVICE WAS SET ASIDE, AND A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT AS THE DEFECTIVE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. THE REPORTED DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE IS CURRENTLY IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343821 VENACURE NEVERTOUCH ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS 600602

    Patients

    Seq Age Sex Outcome Treatment
    1