BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR PREMIER 90 ELECTRODE

    MDR report key: 1633917 · Received March 5, 2010

    Report

    Report Number
    1221934-2010-00100
    Event Type
    Malfunction
    Date Received
    March 5, 2010
    Date of Event
    February 24, 2010
    Report Date
    February 24, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    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 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

    SURGEON WAS USING THE VAPR TO CLEAR THE UNDERSIDE OF THE ACROMION AND TO CLEAR BURSA IN THE SUBACROMIAL SPACE. HE DID NOT USE THE VAPR ELECTRODE FOR A PROLONGED PERIOD OF TIME AND LIFTED HIS FOOT OF THE FOOTPEDAL FREQUENTLY. DESPITE THIS, THE FLUID IN THE JOINT SPACE BECAME VERY HOT, THE ELECTRODE SHAFT STARTED TO MELT AND BECAME BENT AND THE PATIENT RECEIVED BURNS TO THE SKIN ON THEIR SHOULDER LATERALLY. THEY REPORT THAT NO TREATMENT TO THE BURNS WERE NECESSARY. THE DEFAULT SETTING OF 240/120 WAS USED. CONTINUED TO USE THE SAME VAPR BUT USED IT FOR A SHORTER PERIOD THAN WOULD NORMALLY DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK VAPR PREMIER 90 ELECTRODE ELECTROSURGICAL, CUTTING AND COAGULATING GEI DEPUY MITEK 227204 0908070

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK