BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR S90 SUCTION ELECTRODE W/INTEGRATED HANDPIECE

    MDR report key: 3803168 · Received May 9, 2014

    Report

    Report Number
    1221934-2014-00166
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    February 10, 2013
    Report Date
    April 3, 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. THE EVENT DATE REPORTED TO DEPUY MITEK APPEARS TO HAVE AN INCORRECT YEAR (2013), THE DATE WILL BE CONFIRMED AND CORRECTED AS NEEDED VIA A FOLLOW-UP MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION TILL DATE AND THEREFORE THE REPORTED FAILURE CANNOT BE VERIFIED. IT CANNOT BE DETERMINED IF THE ACTIVE TIP SUSTAINED ANY DAMAGE THAT LED TO THIS TYPE OF FAILURE. 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.¿ NO FURTHER INFORMATION WAS AVAILABLE TO DETERMINE IF THE ABOVE MENTIONED FACTORS CONTRIBUTED TO THIS FAILURE. 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. THE COMPLAINT RATES WERE REVIEWED AGAINST THE RISK ANALYSIS DOCUMENTS AND FOUND TO BE WITHIN EXPECTED LEVELS. SINCE THE FUNCTION OF THE ELECTRODE IS TO ABLATE TISSUE, THE RISK ASSOCIATED WITH SPARKING OF THE ELECTRODE TIP WITHIN THE JOINT SPACE IS LOW. 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. NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING THE EVENT DATE WHICH APPEARS TO BE INCORRECT.

    Description of Event or Problem · 1

    DURING A SHOULDER DECOMPRESSION, THE INSTRUMENT WAS INSERTED INTO THE SHOULDER AND USED AS PER MANUFACTURING GUIDELINES. ONCE DIATHERMY COMMENCED THE ELECTRODE WAS NOT WORKING AS IT SHOULD BE AND SPARKS WERE SURROUNDING THE END OF THE ELECTRODE. THE INSTRUMENT WAS TAKEN OUT AND INSPECTED. BLACK CHAR MARKS WERE FOUND AROUND THE INSOLENT MATERIAL AT THE END OF THE ELECTRODE. THE PROBE WAS DISCONNECTED AND PUT INTO QUARANTINE. THE PROBE WAS PLACED INTO QUARANTINE. THE COMPANY REPS WERE MADE AWARE. ANOTHER PROBE WAS USED.

    Description of Event or Problem · 1

    DURING A SHOULDER DECOMPRESSION, THE INSTRUMENT WAS INSERTED INTO THE SHOULDER AND USED AS PER MANUFACTURING GUIDELINES. ONCE DIATHERMY COMMENCED THE ELECTRODE WAS NOT WORKING AS IT SHOULD BE AND SPARKS WERE SURROUNDING THE END OF THE ELECTRODE. THE INSTRUMENT WAS TAKEN OUT AND INSPECTED. BLACK CHAR MARKS WERE FOUND AROUND THE INSOLENT MATERIAL AT THE END OF THE ELECTRODE. THE PROBE WAS DISCONNECTED AND PUT INTO QUARANTINE. THE PROBE WAS PLACED INTO QUARANTINE. THE COMPANY REPS WERE MADE AWARE. ANOTHER PROBE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281372 MITEK VAPR S90 SUCTION ELECTRODE W/INTEGRATED HANDPIECE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA U1311069

    Patients

    Seq Age Sex Outcome Treatment
    1