BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR S90 4MM 90 DEGREE SUCTION ELECTRODE

    MDR report key: 3900526 · Received June 27, 2014

    Report

    Report Number
    1221934-2014-00265
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 30, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K082643
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED FOR EVALUATION 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 PROVIDED TO DETERMINE IF THE ABOVE MENTIONED FACTORS CONTRIBUTED TO THIS FAILURE. DUE TO AN INCREASING TREND IN THE NUMBER OF THIS REPORTED FAILURE. A SUPPLIER CAPA HAS BEEN INITIATED TO INVESTIGATE THIS FAILURE. FOUR POSSIBLE ROOT CAUSES HAVE BEEN IDENTIFIED RELATED TO DESIGN, MANUFACTURING AND USE. CORRECTIVE ACTIONS WHICH INVOLVE DESIGN AND PROCESS IMPROVEMENT ACTIVITIES WERE IDENTIFIED FOR EACH OF THE ROOT CAUSE AND ARE BEING CURRENTLY INVESTIGATED. 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 THREE SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. 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. HOWEVER, 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

    THE HOSPITAL MENTIONED THAT THERE WAS A SMALL FLASH FIRE COMING OUT OF THE VAPR THREE TIMES AND THE LAST ONE WAS A LITTLE BIT BIGGER. ADDITIONAL INFORMATION FROM THE AFFILIATE 6-11-14; ARTHROSCOPIC SHOULDER PROCEDURE, NO DEBRIS INSIDE THE PATIENT, INCIDENT TOOK PLACE OUTSIDE THE PATIENT, BY ACTIVATING THE ELECTRODE ELECTRODES HAVE NOT BEEN IN THE NEIGHBOURHOOD OF METAL. SEE ASSOCIATED MEDWATCH # 1221934-2014-00264.

    Description of Event or Problem · 1

    THE HOSPITAL MENTIONED THAT THERE WAS A SMALL FLASH FIRE COMING OUT OF THE VAPR THREE TIMES AND THE LAST ONE WAS A LITTLE BIT BIGGER. ADDITIONAL INFORMATION FROM THE AFFILIATE (B)(4) 2014; ARTHROSCOPIC SHOULDER PROCEDURE, NO DEBRIS INSIDE THE PATIENT, INCIDENT TOOK PLACE OUTSIDE THE PATIENT, BY ACTIVATING THE ELECTRODE. ELECTRODES HAVE NOT BEEN IN THE NEIGHBOURHOOD OF METAL. SEE ASSOCIATED MEDWATCH # 1221934-2014-00264.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377204 MITEK VAPR S90 4MM 90 DEGREE SUCTION ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA U1401177

    Patients

    Seq Age Sex Outcome Treatment
    1