BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR S90 SUCTION ELECTRODE WITH HAND CONTROL

    MDR report key: 3925478 · Received July 10, 2014

    Report

    Report Number
    1221934-2014-00285
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K120095
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED FOR EVALUATION, THEREFORE, A ROOT CAUSE FOR THIS FAILURE CANNOT BE DETERMINED. HOWEVER, FROM PAST INVESTIGATIONS OF SIMILAR FAILURES, IT WAS DETERMINED THAT ANY DAMAGE TO THE ACTIVE TIP WOULD LEAD TO ELECTRODE SPARKING/ ARCING. THIS DAMAGE TO THE ACTIVE TIP IS LIKELY TO BE CAUSED BY THE INTRODUCTION OF ANOTHER METAL INSTRUMENT DURING THE PROCEDURE. THE IFU STATES: ¿OBSERVE EXTREME CAUTION WHEN USING ELECTROSURGERY 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 PROCEDURAL DETAILS WERE PROVIDED TO DETERMINE IF AFOREMENTIONED CAUSES CONTRIBUTED TO THIS EVENT. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. AT THIS POINT IN TIME, BASED ON THE COMPLAINT HISTORY, NO FURTHER ACTION IS WARRANTED. 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 SALES REP REPORTED THAT DURING A ROTATOR CUFF REPAIR THAT THE CUSTOMER'S VAPR S90 ELECTRODE W/HAND CONTROL WAS SPARKING. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP WAS NOT PRESENT AND COULD NOT CONFIRM IF THE DEVICE WAS IN THE JOINT SPACE AT THE TIME IT WAS SPARKING OR IF ANY DEBRIS WAS PRESENT, BUT VERIFIED THE CUSTOMER DID NOT EXPRESS THAT THERE WAS ANY DEBRIS AND THAT AFTER THE FIRST SPARK THE SURGEON REMOVED THE DEVICE AND STARTED USING ANOTHER ONE. THE CUSTOMER ALREADY DISCARDED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403329 MITEK VAPR S90 SUCTION ELECTRODE WITH HAND CONTROL ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1