BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR III GENERATOR

    MDR report key: 2213947 · Received August 17, 2011

    Report

    Report Number
    1221934-2011-00303
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    August 8, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K041135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RECEIVED AND WAS EVALUATED. FUNCTIONALLY AND ELECTRICALLY, THE UNIT WAS SUBJECTED TO A THOROUGH BATTERY OF TEST. THE UNIT PASSED ALL TEST, FUNCTIONED WELL WITHIN ITS DESIGN AND MANUFACTURED PARAMETERS; COULD FIND NO FAULT WHATSOEVER WITH THE DEVICE; THE UNDERLYING CAUSE FOR THE REPORTED EVENT LIES ELSEWHERE, OUTSIDE OF ANY INFLUENCE OF THE MITEK DEVICE. WE CANNOT DISCERN ANY ROOT CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE 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.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RECEIVED AND WAS EVALUATED. VISUALLY, THE DEVICE HAD SOME MINOR COSMETIC DEFECTS TO ITS CHASSIS, NOTHING GROSS OR INFLUENTIAL. FUNCTIONALLY, THE UNIT WAS SUBJECTED TO A THOROUGH BATTERY OF TEST: THE "COMPLETE PRESSURE ADJUSTER" WAS ADJUSTED BECAUSE THE UNIT KEPT LOOSING PRESSURE DURING TESTING, WHICH CAUSED THE PUMP TO CONTINUOUSLY RUN. OUTSIDE OF THIS, THE UNIT PASSED ALL TEST, FUNCTIONED WELL WITHIN ITS DESIGN AND MANUFACTURED PARAMETERS; COULD FIND NO OTHER FAULT WITH THE DEVICE. THIS VAPR GENERATOR IS A 2009 DEVICE, AND WE CANNOT FIND ANY EVIDENCE THAT IT HAS EVER BEEN PREVIOUSLY SENT IN FOR ANY REPAIR OR GENERAL MAINTENANCE. THE "COMPLETE PRESSURE ADJUSTER" ANOMALY WAS MOST LIKELY "A" CONTRIBUTOR TO THE REPORTED ISSUE, BUT SURLY NOT THE SOLE ROOT CAUSE. THE DEVICE HAS BEEN FULLY REPAIRED AND REFURBISHED AS NEEDED; 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.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING THAT DURING AN UNKNOWN PROCEDURE, ONE OF THE STAFF ATTEMPTED TO PLUG A VAPR ELECTRODE AND HANDPIECE INTO THE GENERATOR: THERE WAS SOME SORT OF A "SHORTING" EXPERIENCE: ELECTRICAL SPARKING AND ARCING, A SLIGHT ENERGY NOISE AND THE STAFF PERSON RECEIVED A SLIGHT SHOCK. THERE WAS NO HARM TO THE STAFF. IT IS NOT KNOWN HOW THE PROCEDURE WAS CONCLUDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1