BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR S90 SUCTION ELECTRODE W/INTEGRATED HANDPIECE

    MDR report key: 3934584 · Received July 15, 2014

    Report

    Report Number
    1221934-2014-00296
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 19, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K082643
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 AND THE MANIFOLD BETWEEN 7 - 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 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. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. HOWEVER IN THE INTEREST OF CONTINUOUS IMPROVEMENT, SUPPLIER (B)(4) HAS BEEN INITIATED TO INVESTIGATE AND DETERMINE A ROOT CAUSE FOR THIS FAILURE. THIS CAPA IS MONITORED UNDER MITEK NC-040745. 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

    THE PATIENT IS FEMALE AND (B)(6). WHEN THE SURGEON USED VAPR S90 TO CLEAR KNEE JOINT FOR MENISCUS REPAIR, A FIRE SPARKLE WAS NOTED SUDDENLY FROM THE DEVICE. THE SURGEON HAD TO TOOK IT OUT FROM THE PATIENT&'S KNEE IMMEDIATELY, AND CHANGED THE OTHER ONE TO CONTINUE THE SURGERY. NO ADVERSE EVENT ON THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT IS FEMALE AND (B)(6). WHEN THE SURGEON USED VAPR S90 TO CLEAR KNEE JOINT FOR MENISCUS REPAIR, A FIRE SPARKLE WAS NOTED SUDDENLY FROM THE DEVICE. THE SURGEON HAD TO TOOK IT OUT FROM THE PATIENT'S KNEE IMMEDIATELY ,AND CHANGED THE OTHER ONE TO CONTINUE THE SURGERY. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412576 MITEK VAPR S90 SUCTION ELECTRODE W/INTEGRATED HANDPIECE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1