BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK VAPR COOLPULSE 90 ELECTRODE

    MDR report key: 4201628 · Received October 27, 2014

    Report

    Report Number
    1221934-2014-00468
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K100638
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    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. DEVICE EVAL: IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION CONFIRMS THE ACTIVE TIP IS BROKEN AND THE CERAMIC ON THE DISTAL TIP SHOWED SIGNS OF ACTIVATION. IT WAS NOTED THAT THE ACTIVE SUCTION TUBE HAS ERODED DURING USE AND THERE IS A SECTION OF THE ACTIVE SUCTION TUBE WHICH IS BELIEVED TO BE ERODED AWAY DUE TO EXCESSIVE USE AND WOULD NOT HAVE DEPOSITED INTO THE PATIENT JOINT SPACE. NO ELECTRICAL OR FUNCTIONAL TESTS WERE CONDUCTED DUE TO THE CONDITION OF THE ELECTRODE. THIS FAILURE IS BEING INVESTIGATED UNDER SUPPLIER CAPA. ROOT CAUSE: THE CURRENT DESIGN HEAVILY RELIES ON THE EPOTEK WITHIN THE DISTAL ASSEMBLY TO WITHSTAND MECHANICAL STRESSES DURING AGGRESSIVE TISSUE TEST AND TO PROTECT THE STAINLESS STEEL FROM CHEMICAL EROSION. DURING USE OF AN ELECTRODE THE WELD JOINT BETWEEN ACTIVE TIP AND ACTIVE SUCTION TUBE WEAKENS DUE TO MECHANICAL FATIGUE, CHEMICAL EROSION AND A COMBINATION OF BOTH (STRESS CORROSION PITTING). THE WELD BRIDGE RECEIVES MECHANICAL STRESSES ABOVE YIELD. CORRECTIVE ACTIONS INVOLVING DESIGN CHANGES ARE BEING INVESTIGATED CURRENTLY. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. A REVIEW INTO THE COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. THE OBSERVED COMPLAINT RATE IS 0.005% AND IS WELL BELOW THE EXPECTED RATE OF 0.05% PER THE RISK ASSESSMENT. (B)(4) 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 SALES REP REPORTED THAT DURING A SHOULDER REPAIR THAT THE METAL FACEPLACE OF THE CUSTOMER'S VAPR COOL PULSE 90 ELECTRODE WITHOUT HAND CONTROLS FELL OFF INSIDE THE PATIENT'S JOINT SPACE. THE SALES REP REPORTED THAT THE SURGEON USED THIS DEVICE INTERMITTENTLY FOR 20 MINUTES AT FULL CAPACITY BEFORE THE FACEPLATE FELL OFF THE DEVICE. THE SURGEON RETRIEVED THE BROKEN FACEPLATE AFTER DOING X-RAYS. THE SURGEON NEXT USED ANOTHER SAME LIKE DEVICE WHICH HAD ITS FACEPLACE BECOME DISLODGED FROM THE TIP OF THE WAND BUT DID NOT FULLY COME OFF. THE SURGEON USED THIS 2ND SAME LIKE DEVICE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THERE WAS A 45 MINUTE DELAY IN THE PROCEDURE. THE SALES REP WAS NOT PRESENT AND HAD NO FURTHER INFORMATION. THE DEVICE IS BEING RETURNED FOR EVALUATION. SEE ASSOCIATED MEDWATCH 1221934-2014-00469.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING A SHOULDER REPAIR THAT THE METAL FACEPLACE OF THE CUSTOMER'S VAPR COOL PULSE 90 ELECTRODE WITHOUT HAND CONTROLS FELL OFF INSIDE THE PATIENT'S JOINT SPACE. THE SALES REP REPORTED THAT THE SURGEON USED THIS DEVICE INTERMITTENTLY FOR 20 MINUTES AT FULL CAPACITY BEFORE THE FACEPLATE FELL OFF THE DEVICE. THE SURGEON RETRIEVED THE BROKEN FACEPLATE AFTER DOING X-RAYS. THE SURGEON NEXT USED ANOTHER SAME LIKE DEVICE WHICH HAD ITS FACEPLACE BECOME DISLODGED FROM THE TIP OF THE WAND BUT DID NOT FULLY COME OFF. THE SURGEON USED THIS 2ND SAME LIKE DEVICE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THERE WAS A 45 MINUTE DELAY IN THE PROCEDURE. THE SALES REP WAS NOT PRESENT AND HAD NO FURTHER INFORMATION. THE DEVICE IS BEING RETURNED FOR EVALUATION. SEE ASSOCIATED MEDWATCH 1221934-2014-00469.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682036 MITEK VAPR COOLPULSE 90 ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA U1406095

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R