BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR GENERATOR

    MDR report key: 2183001 · Received July 28, 2011

    Report

    Report Number
    1221934-2011-00282
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K041135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OF THE COMPLAINT DEVICES WITHIN THIS ISSUE WERE RECEIVED AT MITEK AND THEN FORWARDED TO THE MANUFACTURER FOR A THOROUGH AND COMPLETE EVALUATION TOWARDS DETERMINING A ROOT CAUSE FOR THE REPORTED EVENT IF POSSIBLE. THE MANUFACTURER CONDUCTED REVIEWS OF THE DEVICE BUILD HISTORY RECORDS TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. THEIR RESULTS INDICATE THAT THESE BATCHES OF PRODUCTS (THE GENERATOR/PART # 225021/SN (B)(4), THE FOOTSWITCH/PART # 225023/LOT # 0904040 AND THE LPS ELECTRODE/PART # 225361/LOT # M1009046) WERE PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. ADDITIONALLY, MITEK CONDUCTED A REVIEW INTO ITS COMPLAINTS SYSTEM FOR THESE COMPLAINT DEVICES, WHICH REVEALED THAT THERE WERE NO OTHER SIMILAR COMPLAINT FOR THESE COMPLAINT LOTS THAT WERE RELEASED TO DISTRIBUTION. DUE TO THE POOR CONDITION OF THE HANDPIECE, THE LOT NUMBER WAS NOT ABLE TO BE IDENTIFIED, WHICH PRECLUDES CONDUCTING ANY RECORDS REVIEW FOR IT. THE DEVICES WERE ASSEMBLED INTO A SYSTEM AND THEN TESTED AS A SYSTEM. THE SYSTEM AS A WHOLE AND THE INDIVIDUAL ANCILLARY DEVICES WERE SUBJECTED TO A BATTERY OF TEST, TO INCLUDE: ELECTRICAL TEST (CAPACITOR, CONTINUITY ACTIVE, CONTINUITY RETURN AND HIPOT); FUNCTIONAL TEST (DEFAULT SETTING, MAX SETTING, MIN SETTING AND RANGE AVAILABLE). THE ELECTRODE TIP WAS TESTED FOR CUT AND COAG SETTINGS WITH NO FAULT FOUND. OTHER ELECTRICAL/FUNCTIONAL TEST PERFORMED INCLUDED; EARTH LEAKAGE, PATIENT LEAKAGE, EARTH CONTINUITY, DIELECTRIC, ETC. WE COULD FIND NO FAULT WITH THE SYSTEM AS A HOLE, OR THE INDIVIDUAL ANCILLARY DEVICES. IN SUMMARY AND CONCLUSION: THE SYSTEM WAS EVALUATED VISUALLY, ELECTRICALLY AND FUNCTIONALLY. THERE WERE NO SIGNS OF DAMAGE TO EITHER THE ELECTRODE OR THE HANDPIECE. THE GENERATOR HAD SOME MINOR SCRATCHES TO ITS CHASSIS, THERE WERE NO GROSS FAULTS OR DAMAGE. WHEN THE SYSTEM IN TOTAL WAS TESTED, IT PASSED ALL ELECTRICAL AND FUNCTIONAL PARAMETERS, THE CORRECT SETTINGS WERE DISPLAYED AND MADE AVAILABLE ON THE GENERATOR AND THE SYSTEM PASSED ALL FUNCTIONAL TESTING WITH NO ERROR MESSAGES BEING DISPLAYED. THE FAULT REPORTED IN THE COMPLAINT NARRATIVE BY THE USER COULD NOT BE DUPLICATED. THE INTERNAL QUALITY RECORDS ASSOCIATED WITH THE COMPLAINT DEVICES WERE REVIEWED AND NO INCONSISTENCIES WERE FOUND. THE RETURNED DEVICES MET THEIR SPECIFIED REQUIREMENTS, AND THE REPORTED FAULT COULD NOT BE REPLICATED. WE CAN FIND NO FAULT WITH THE COMPLAINT DEVICES, AND SO, WE CANNOT DISCERN THE ROOT OR UNDERLYING CAUSE FOR THE USER'S REPORTED EXPERIENCE. AT THIS POINT IN TIME NO FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE, GERMANE AND CLARIFYING TO THIS ISSUE. ALSO, 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.

    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.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE WITH THE USE OF VAPR; THE ELECTRODE MADE AN UNUSUAL NOISE DURING ACTIVATION, THE PATIENT'S ARM MOVED, AND THE SURGEON RECEIVED A SHOCK. THE SYSTEM WAS SWAPPED OUT AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. SEE ALSO ASSOCIATED MDRS 1221934-2011-00283, 1221934-2011-00284 AND 1221934-2011-00285.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK VAPR GENERATOR ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1