BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR COOL PULSE 90 ELECTRODE, W/HAND CONTROLS

    MDR report key: 3222364 · Received July 12, 2013

    Report

    Report Number
    1221934-2013-00177
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 1, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K100638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    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

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, WHICH PRECLUDES CONDUCTING AN EVALUATION; HOWEVER, 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 MITEK COMPLAINTS SYSTEM REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT TELL ANYTHING FROM THIS; WE CANNOT DISCERN A ROOT OR UNDERLYING CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO 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.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING A SHOULDER REPAIR, A PORTION OF THE DISTAL TIP OF A MITEK VAPR CP90 ELECTRODE BROKE OFF INTO THE PATIENT¿S BODY. THE FRAGMENT WAS RETRIEVED FROM THE BODY AND THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING ANOTHER SAME DEVICE WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. COMPLAINT DEVICE DISCARDED AT USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324015 MITEK VAPR COOL PULSE 90 ELECTRODE, W/HAND CONTROLS ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA 1303034

    Patients

    Seq Age Sex Outcome Treatment
    1