BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR S90 4MM 90 DEGREE SUCTION ELECTRODE

    MDR report key: 3910372 · Received July 2, 2014

    Report

    Report Number
    1221934-2014-00275
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 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
    FR
    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 WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION OF THE ELECTRODE REVEALS THE DISTAL TIP SHOWS SIGNS OF ACTIVATION. THERE IS TISSUE DEBRIS AROUND THE TIP AND SALINE SOLUTION STAINS ON DEVICE SURFACE AND IN THE SUCTION TUBE. UNDER MAGNIFICATION, IT WAS OBSERVED THAT THE MANIFOLD SHOWS SIGNS OF MELTING BETWEEN 4-5 O'CLOCK POSITIONS OF THE TIP. MOREOVER, THE SUCTION TUBE WAS TIED IN A KNOT FORM, WITHOUT ANY INFORMATION OF WHY OR WHEN IT WAS TIED. THIS DAMAGE TO THE TIP WOULD LEAD TO THE SPARKING OF THE ELECTRODE AND DISPLAY OUTPUT SHORTED ERROR, CONFIRMING THIS COMPLAINT. THIS DAMAGE IS CONSISTENT WITH THE TIP OF THE DEVICE COMING INTO CONTACT WITH A SECONDARY METALLIC OBJECT DURING ACTIVATION, INDICATING MISUSE. THE ELECTRODE WAS NOT TESTED TO AVOID FURTHER DAMAGE TO THE TIP. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR 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. A SUPPLIER CAPA HAS BEEN INITIATED TO INVESTIGATE THE TIP MELTING ISSUE. 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

    ELECTRODE PRODUCED SPARKS. ELECTRODE PRODUCES SPARKS AND WIRES. USE OF ANOTHER ELECTRODE.

    Description of Event or Problem · 1

    ELECTRODE PRODUCED SPARKS. ELECTRODE PRODUCES SPARKS AND WIRES. USE OF ANOTHER ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387769 MITEK VAPR S90 4MM 90 DEGREE SUCTION ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA U1401279

    Patients

    Seq Age Sex Outcome Treatment
    1