BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPR SE ELECTRODE

    MDR report key: 2010773 · Received March 2, 2011

    Report

    Report Number
    1221934-2011-00079
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A F/U REPORT.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR PROCEDURE, 2 VAPR ELECTRODES FAILED TO WORK; THESE WERE THE ONLY TWO ELECTRODES THAT THE FACILITY HAD IN THEIR INVENTORY, THEY ONLY CARRY 2 AT A TIME IN THEIR STOCK. AT THIS POINT, THE PT WAS UNDER ANESTHESIA, AND THE PROCEDURE WAS ABANDONED. THE COMPLAINT DEVICES WERE DISCARDED AT THE USER FACILITY. THIS IS ALL OF THE INFO MADE AVAILABLE SO FAR; THERE ARE QUESTIONS OUT FOR FURTHER INFO AND DETAIL. ALSO SEE ASSOCIATED MDR 1221934-2011-00080.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR SE ELECTRODE ELECTROSURGICAL, CUTTING AND COAGULATING GEI DEPUY MITEK 337201 M1003117

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention