BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR COOLPULSE 90 ELECTRODE

    MDR report key: 4243568 · Received November 11, 2014

    Report

    Report Number
    1221934-2014-00491
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 17, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K100638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK HOWEVER IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE, DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT. AWAITING RETURN.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. DEVICE IS CURRENTLY UNDER INVESTIGATION. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION UNDER MAGNIFICATION REVEALED A SMALL FRAGMENT OF THE CERAMIC SURROUNDING THE ACTIVE TIP WAS BROKEN. THERE WAS SALINE RESIDUE IN THE SUCTION TUBE INDICATING THE DEVICE HAD BEEN USED. MOREOVER, THERE WERE MULTIPLE SCRATCHES ON THE SHAFT¿S HEAT SHRINK LAYER, INDICATING THAT THERE WERE SHARP OBJECTS CLOSE TO THE ELECTRODE DURING USAGE. THE DAMAGE TO THE ACTIVE TIP IS LIKELY TO BE CAUSED BY THE INTRODUCTION OF ANOTHER METAL INSTRUMENT DURING THE PROCEDURE. THE IFU STATES: ¿OBSERVE EXTREME CAUTION WHEN USING ELECTRO SURGERY IN CLOSE PROXIMITY TO OR IN DIRECT CONTACT WITH ANY METAL OBJECTS. THE MAJORITY OF ARTHROSCOPES AND ARTHROSCOPIC INSTRUMENTS ARE METAL. DO NOT ACTIVATE THE ELECTRODE WHILE ANY PORTION OF THE ELECTRODE AND THE ADJACENT METAL OBJECT MAY RESULT IN PRODUCT DAMAGE.¿ THE ELECTRODE WAS CONNECTED TO A VAPR VUE GENERATOR AND ALL CORRECT DEFAULT SETTINGS WERE MADE AVAILABLE. THE GENERATOR WAS SET TO MAXIMUM POWER FOR ABLATION AND COAGULATION MODES AND ACTIVATED IN SALINE SUCCESSFULLY INDICATING THAT THE DEVICE WAS FIT FOR FUNCTION AT THE TIME OF USE. THE ELECTRODE WAS TESTED SEVERAL TIMES TO ENSURE CONTINUITY OF FUNCTION. THIS COMPLAINT CAN BE CONFIRMED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE, THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED ONE OTHER DISSIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE ELECTRODE HAS LOST ITS WHITE CERAMIC. THE PIECE OF THE DEVICE DETACHED AND WAS REMOVED OUT OF THE PATIENT SHOULDER. NO CONSEQUENCES TO THE PATIENT-ANOTHER LIKE DEVICE WAS USED.

    Description of Event or Problem · 1

    THE ELECTRODE HAS LOST ITS WHITE CERAMIC. THE PIECE OF THE DEVICE DETACHED AND WAS REMOVED OUT OF THE PATIENT SHOULDER. NO CONSEQUENCES TO THE PATIENT-ANOTHER LIKE DEVICE WAS USED.

    Description of Event or Problem · 1

    THE ELECTRODE HAS LOST ITS WHITE CERAMIC. THE PIECE OF THE DEVICE DETACHED AND WAS REMOVED OUT OF THE PATIENT SHOULDER. NO CONSEQUENCES TO THE PATIENT-ANOTHER LIKE DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727471 MITEK VAPR COOLPULSE 90 ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA U1403189

    Patients

    Seq Age Sex Outcome Treatment
    1