BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELIMINATOR ICW

    MDR report key: 9822033 · Received March 11, 2020

    Report

    Report Number
    3006524618-2020-00103
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 15, 2020
    Report Date
    July 3, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470001860
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE DEVICE REPORTED, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THE RELATIONSHIP BETWEEN THE PRODUCT AND REPORTED INCIDENT CANNOT BE ESTABLISHED. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2031527 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. WITHOUT THE REPORTED PRODUCT A VISUAL INSPECTION AND FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND CUSTOMER´S COMPLAINT CANNOT BE CONFIRMED. POTENTIAL FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT MAY LEAD TO THE FAILURE REPORTED INCLUDE, BUT ARE NOT LIMITED TO: NOT HAVING SUFFICIENT SALINE IN ORDER TO FACILITATE THE FORMATION OF PLASMA, INADEQUATE SUCTION, NOT HAVING THE WAND OR FOOT CONTROL CONNECTOR FULLY INSERTED INTO THE CONTROLLER DISPLAY, OR CONTROLLER OR FOOT CONTROL DAMAGED WHICH WERE NOT RETURNED FOR EVALUATION. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    THE ELIMINATOR ICWI WAND, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS NOT ESTABLISHED. A REVIEW OF MANUFACTURING AND STERILIZATION RECORDS FOR THE REPORTED LOT NUMBER 2031527 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND NO RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. VISUAL INSPECTION UNDER MAGNIFICATION SHOWS NO ELECTRODE EROSION OF THE ELECTRODE. THERE ARE NO MANUFACTURING ABNORMALITIES VISUALLY OBSERVED WITH THE RETURNED DEVICE. THE WAND WAS CONNECTED TO A COMPATIBLE CONTROLLER, ACTIVATED IN SALINE SOLUTION USING ABLATION/COAG DEFAULT AND MAX SETTINGS AND PLASMA WAS OBSERVED AS INTENDED. THE COMPLAINT WAS NOT VERIFIED AS THE DEVICE SUCCESSFULLY GENERATED PLASMA AND COAGULATION. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, POTENTIAL FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT MAY LEAD TO THE FAILURE REPORTED INCLUDE, BUT ARE NOT LIMITED TO: NOT HAVING SUFFICIENT SALINE IN ORDER TO FACILITATE THE FORMATION OF PLASMA, OR THE WAND OR FOOT CONTROL CONNECTOR MAY HAVE BECOME DISCONNECTED FROM THE CONTROLLER DISPLAY. FACTORS UNRELATED TO THE MANUFACTURE OR DESIGN OF THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT IS THE CONTROLLER OR FOOT CONTROL WHICH WERE NOT RETURNED FOR EVALUATION. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A PROCEDURE, THE ELIMINATOR ICW WAS NOT ABLATING OR COAGULATING. THE SETTINGS WERE SHOWING IN THE CONTROLLER. THE PEDAL WAS NOT ACTIVATING THE WAND EITHER. AFTER DISCONNECTING AND RECONNECTING THE PEDAL, THE WAND STILL DID NOT WORK. THE CONTROLLER WAS TURNED OFF AND ON AGAIN AND THE WAND STILL DID NOT WORK. THE DOCTOR COMPLETED THE PROCEDURE WITH AN ELECTRO-SCALPEL. NO SIGNIFICANT DELAY OR PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278579 ELIMINATOR ICW ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. AC1345-01 2031527 00817470001860

    Patients

    Seq Age Sex Outcome Treatment
    1