BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR P90 ELECTRODE

    MDR report key: 3052159 · Received April 11, 2013

    Report

    Report Number
    1221934-2013-00097
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K082643
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 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

    FIFTY DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO US, AND NOTHING IS 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.

    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 AFFILIATE IS REPORTING TO US THAT DURING A PROCEDURE, A PORTION OF THE DISTAL TIP OF A MITEK VAPR P90 ELECTRODE BROKE OFF AND FELL INTO THE PATIENT'S JOINT SPACE. THE FRAGMENT WAS EASILY RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. THE PROCEDURE WAS EXTENDED BY 35 MINUTES BECAUSE OF THIS. THE COMPLAINT DEVICE WAS DISCARDED AT THE USER FACILITY.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING A PROCEDURE, A PORTION OF THE DISTAL TIP OF A MITEK VAPR P90 ELECTRODE BROKE OFF AND FELL INTO THE PATIENT¿S JOINT SPACE. THE FRAGMENT WAS EASILY RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. THE PROCEDURE WAS EXTENDED BY 35 MINUTES BECAUSE OF THIS. THE COMPLAINT DEVICE WAS DISCARDED AT THE USER FACILITY.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING A PROCEDURE, A PORTION OF THE DISTAL TIP OF A MITEK VAPR P90 ELECTRODE BROKE OFF AND FELL INTO THE PATIENT'S JOINT SPACE. THE FRAGMENT WAS EASILY RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155203 MITEK VAPR P90 ELECTRODE ELECTROSURICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA 1206067

    Patients

    Seq Age Sex Outcome Treatment
    1