BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR S90 ELECTRODE

    MDR report key: 2121186 · Received June 13, 2011

    Report

    Report Number
    1221934-2011-00234
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K041135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    MITEK HAS RECEIVED AND EVALUATED THE COMPLAINT DEVICE. BASED ON THE CONDITION OF THE DAMAGE, FUNCTIONAL TESTING WAS MEANINGLESS, HOWEVER, THE DEVICE WAS EXAMINED VISUALLY, BOTH WITH THE NAKED EYE AND UNDER POWER. IT IS NOTED THAT THERE ARE SOME VISUAL DEFECTS WITHIN THE 3-9 O' CLOCK POSITION. IT APPEARS THAT THE MATERIAL AT THE LOWER HALF OF THE ELECTRODE TIP, HAS MELTED AND MIGRATED INWARD TOWARDS THE CENTER. 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 FOUR DISSIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. THE REPORTED ISSUES WITH THE DISTAL TIP OF S90 AND LPS ELECTRODES HAS BEEN THE FOCUS OF A LONG AND INTENSIVE INVESTIGATION, WHICH HAS BEEN CONDUCTED IN COLLABORATION WITH MITEK AND THE MANUFACTURER. THE BULK OF THE RETURNED S90 DEVICES WITH REPORTED DISTAL TIP FAILURE MODES: SPARKING AND ARCHING, MISSING MASS, BREAKING OFF, ETC., HAVE BEEN RECEIVED AT MITEK, VISUALLY EVALUATED TO SUBSTANTIATE THE FAILURE MODE, AND THEN WERE FORWARDED TO THE MANUFACTURER TO SUPPORT THEIR ONGOING INVESTIGATION TOWARDS DETERMINING WHAT THE ROOT CAUSE OR UNDERLYING REASON FOR THESE ISSUES COULD BE. TO DATE, THE ANALYSIS OF COMPLAINT DEVICES FOR THIS FAILURE MODE HAS NOT BEEN ABLE TO DETERMINE A SPECIFIC ROOT CAUSE FOR EACH OF THE DEVICE FAILURES, AND HAS ALSO NOT BEEN ABLE TO IDENTIFY A GENERIC ROOT CAUSE TO EXPLAIN THE FAILURES AS A WHOLE. PRODUCT PROBLEM INVESTIGATIONS AND CORRECTIVE ACTION ACTIVITY HAVE NOT YIELDED ANY FAILURE REASONS THAT ARE OUTSIDE OF THE HISTORICAL HYPOTHESIS THAT TECHNIQUE IS THE MOST LIKELY DRIVING FACTOR: TIP BURIAL ACTIVATION: THIS CAN CAUSE CARBON TRACKING BETWEEN ACTIVE AND RETURN CREATING AN "OUTPUT SHORT" ERROR CODE ON THE GENERATOR; THIS IS CONSIDERED TO BE A USER ISSUE AND EXTERNAL FAILURE. ACTIVATION OUTSIDE OF THE SALINE FIELD: THIS CAN CAUSE THERMAL DAMAGE TO THE TIP, IN TURN REDUCING THE DISTANCE BETWEEN THE ACTIVE AND RETURN PATHS; ALSO, THE FAILURE MODE AND FREQUENCY RATE FOR THIS DEVICE ARE WELL WITHIN THE FMEA RISK ANALYSIS. BEYOND OUR HYPOTHESIS AND CONSIDERATION, WE CANNOT DISCERN ANY OTHER ROOT CAUSE FOR THESE ISSUES. OUTSIDE OF CONTINUED ANALYSIS ACTIVITY AND TRENDING, NO FURTHER ACTION IS WARRANTED AT THIS TIME, HOWEVER, IF AND WHEN A DEFINITIVE ROOT CAUSE CAN BE DETERMINED, IT WILL BE NOTED IN ANY FUTURE RELATIVE EVALUATION SUMMARIES.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC KNEE REPAIR, A PORTION OF THE DISTAL TIP, OR SOME OF THE INSULATION COATING AT THE DISTAL TIP CAME OFF INTO THE PATIENT&APOS'S JOINT SPACE. IT IS NOT KNOWN IF ALL OF THE FRAGMENTS/DEBRIS WAS REMOVED FROM THE JOINT SPACE; HOWEVER, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK VAPR S90 ELECTRODE ELECTROSURGICAL: CUTTING & COAGULATING GEI DEPUY MITEK NA M1003159R

    Patients

    Seq Age Sex Outcome Treatment
    1