BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR S90 ELECTRODE WITH INTEGRATED HANDPIECE

    MDR report key: 3840332 · Received May 30, 2014

    Report

    Report Number
    1221934-2014-00211
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K082643
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 OBSERVATION OF THE ACTIVE TIP INDICATES SIGNS OF ACTIVATION AND THE MANIFOLD BETWEEN 4 - 9 O'CLOCK POSITIONS OF THE TIP SHOWS SIGNS OF MELTING. THIS DAMAGE TO THE ACTIVE TIP WOULD LEAD TO THE REPORTED FAILURE, CONFIRMING THIS COMPLAINT. NO FUNCTIONAL TEST WAS CONDUCTED TO AVOID FURTHER DAMAGE. THE DEVICE PASSED ALL THE ELECTRICAL TESTS. THE SHARP EDGES OF THE TIP PROFILE CONFIRM THE CUSTOMER REPORT THAT THE DEVICE HAD NOT BEEN ACTIVATED FOR A LENGTHY PERIOD. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE 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 MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. DUE TO AN INCREASING TREND IN THE NUMBER OF MELTED MANIFOLD FAILURE, SUPPLIER CAPA HAS BEEN INITIATED TO INVESTIGATE AND DETERMINE A ROOT CAUSE FOR THIS FAILURE. MITEK NC CAPTURES THE RESULTS OF THIS SUPPLIER CAPA. DEPUY 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

    AFTER THE ELECTRODE HAD BEEN USED FOR 2 MINUTES, THE GENERATOR WOULD DISPLAY ¿OUTPUT SHORTED¿ BUT WOULD NOT RESET ITSELF AUTOMATICALLY. THE BLACK MODE BUTTON WOULD BE PUSHED AND THE ELECTRODE WOULD WORK ONLY FOR A SHORT AMOUNT OF TIME. THE PLASTIC SURROUNDING THE ELECTRODE SEEMED TO DISINTEGRATE AND LEAVE A BLACK MARK IN THE SOFT TISSUE. SURGEON USED ANOTHER S90 ELECTRODE. THE FOLLOWING UPDATED INFORMATION WAS RECEIVED FROM OUR AFFILIATE SALES REP ON 5-20-14; THE WHITE PLASTIC SURROUNDING THE ACTIVE TIP OF THE ELECTRODE SEEMED TO DISINTEGRATE AND LEAVE A BLACK MARK (LOOKS LIKE THE BURNT PLASTIC) IN THE SOFT TISSUE. NOTHING WAS LEFT IN THE PATIENT AT THE END OF THE OPERATION. THIS EXTENDED CASE TIME BY 5 MINUTES. STATUS OF PATIENT-NOT KNOWN.

    Description of Event or Problem · 1

    AFTER THE ELECTRODE HAD BEEN USED FOR 2 MINUTES, THE GENERATOR WOULD DISPLAY ¿OUTPUT SHORTED¿ BUT WOULD NOT RESET ITSELF AUTOMATICALLY. THE BLACK MODE BUTTON WOULD BE PUSHED AND THE ELECTRODE WOULD WORK ONLY FOR A SHORT AMOUNT OF TIME. THE PLASTIC SURROUNDING THE ELECTRODE SEEMED TO DISINTEGRATE AND LEAVE A BLACK MARK IN THE SOFT TISSUE. SURGEON USED ANOTHER S90 ELECTRODE. THE FOLLOWING UPDATED INFORMATION WAS RECEIVED FROM OUR AFFILIATE SALES REP ON (B)(4) 2014; THE WHITE PLASTIC SURROUNDING THE ACTIVE TIP OF THE ELECTRODE SEEMED TO DISINTEGRATE AND LEAVE A BLACK MARK (LOOKS LIKE THE BURNT PLASTIC) IN THE SOFT TISSUE. NOTHING WAS LEFT IN THE PATIENT AT THE END OF THE OPERATION. THIS EXTENDED CASE TIME BY 5 MINUTES. STATUS OF PATIENT-NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318165 MITEK VAPR S90 ELECTRODE WITH INTEGRATED HANDPIECE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA U1401176

    Patients

    Seq Age Sex Outcome Treatment
    1