BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR S90 4MM 90 DEGREE SUCTION ELECTRODE

    MDR report key: 3934428 · Received July 15, 2014

    Report

    Report Number
    1221934-2014-00294
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 16, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K082643
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. IN TRANSIT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION OF THE ACTIVE TIP INDICATES SIGNS OF ACTIVATION, THERE WAS SALINE DEBRIS INSIDE THE SUCTION TUBE, SCRATCHES ON THE HEAT SHRINK AND THE MANIFOLD AT 7 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 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.¿ TOUCHING THE TIP OF THE SCOPE DURING USE IS CONTRARY TO THE PRECAUTIONS STATED IN THE IFU AND WOULD CAUSE THE DAMAGE SEEN ON THE ACTIVE TIP. 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 1 SIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. IN THE INTEREST OF CONTINUOUS IMPROVEMENT, A SUPPLIER CAPA HAS BEEN INITIATED TO INVESTIGATE AND DETERMINE A ROOT CAUSE FOR THIS FAILURE. 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.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE ELECTRODE EMITTED SPARKLES AND SUBSEQUENTLY IT STOPPED TO WORK. THE SURGEON USED A NEW ELECTRODE OF THE SAME LOT NUMBERS: ALSO THIS ONE EMITTED SPARKLES AND STOPPED TO WORK. THE PROCEDURE WAS CARRIED OUT AND FINISHED BY USING A NEW DEVICE. NO PATIENT ADVERSE CONSEQUENCES HAVE BEEN REPORTED. SEE ASSOCIATED MEDWATCH # 1221934-2014-00295.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE ELECTRODE EMITTED SPARKLES AND SUBSEQUENTLY IT STOPPED TO WORK. THE SURGEON USED A NEW ELECTRODE OF THE SAME LOT NUMBERS: ALSO THIS ONE EMITTED SPARKLES AND STOPPED TO WORK. THE PROCEDURE WAS CARRIED OUT AND FINISHED BY USING A NEW DEVICE. NO PATIENT ADVERSE CONSEQUENCES HAVE BEEN REPORTED. SEE ASSOCIATED MEDWATCH # 1221934-2014-00295.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412725 MITEK VAPR S90 4MM 90 DEGREE SUCTION ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA U1402116

    Patients

    Seq Age Sex Outcome Treatment
    1