BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR HOOK ELECTRODE

    MDR report key: 1000096 · Received February 1, 2008

    Report

    Report Number
    1221934-2008-00058
    Event Type
    Malfunction
    Date Received
    February 1, 2008
    Date of Event
    December 11, 2007
    Report Date
    January 30, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS NOT SURE IF THEY WILL BE RELEASING THE DEVICE FROM THEIR POSSESION. THEY COULD NOT SUPPLY THE LOT NUMBER, WHICH PRECLUDES CONDUCTING A BATCH RECORD REVIEW TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. HISTORICALLY, THIS TYPE OF FAILURE MODE HAS BEEN ATTRIBUTED TO THE POSSIBILITY THAT, INSTEAD OF THE DEVICE BEING USED IN A WAND-LIKE FASHION, THE ELECTRODE WAS USED AS A HOOK OR PRY BAR, CAUSING THE USER TO APPLY EXCESSIVE MECHANICAL FORCE OR TORQUE TO THE DEVICE, WHICH MAY HAVE PRECIPITATED OR CONTRIBUTED TO THIS INCIDENT. OUTSIDE OF THIS HYPOTHESIS, NO OTHER ROOT CAUSE FOR THE DEVICE FAILURE CAN BE DISCERNED. IF AND WHEN THE COMPLAINT DEVICE IS EVER RECEIVED, IT WILL BE SUBJECTED TO A ROOT CAUSE FAILURE ANALYSIS, IF THE RESULTS OF THAT ANALYSIS DIFFER FROM THE NOTED HYPOTHESIS, THE RESULTS WILL BE THE SUBJECT IN A FOLLOW UP REPORT. AT THIS POINT IN TIME NO FURTHER ACTION IS WARRANTED. HOWEVER, 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

    RECEIVED A MEDWATCH 3500A FROM THE FDA ALERTING US THAT A USER FACILITY REPORTED HAVING HAD THE HOOK OF A HOOK ELECTRODE BREAK OFF INTO A PT'S JOINT SPACE DURING A PROCEDURE. THE FRAGMENT WAS RECOVERED FROM THE BODY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. THIS ISSUE WAS NOT ORIGINALLY REPORTED TO MITEK BY THE USER FACILITY, THEY SUBMITTED A 3500 TO THE FDA REPORTING THE EVENT, WHO IN TURN FORWARDED THE NOTICE TO MITEK FOR REVIEW. AS A RESULT OF THE FDA NOTIFICATION THIS FILE WAS CREATED SO THAT THE REPORTED EVENT COULD BE DOCUMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR HOOK ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATING GEI DEPUY MITEK 225305 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN