BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR TRIGGER-FLEX PROBE

    MDR report key: 1334729 · Received February 26, 2009

    Report

    Report Number
    2428235-2009-00002
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Date of Event
    January 26, 2009
    Report Date
    January 27, 2009
    Manufacturer
    ELLMAN INTERNATIONAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K003126
    Removal / Correction Number
    2428235-11/21/08-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION AND RETURN OF THE DEVICE HAS BEEN REQUESTED BY THE MANUFACTURER MULTIPLE TIMES, BUT NONE HAS BEEN RECEIVED. PREVIOUS INCIDENTS INVOLVING THIS LOT PROMPTED THE LOT TO BE RECALLED IN NOVEMBER 2008. THE DISTRIBUTOR WAS NOTIFIED OF THIS RECALL.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THAT TIP SEPARATED FROM THE DEVICE DURING A LATERAL EXTRAFORMINAL DECOMPRESSION. THE SEPARATED PIECE WAS RETRIEVED BY THE PHYSICIAN AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR TRIGGER-FLEX PROBE GEI ELLMAN INTERNATIONAL, INC. DTF-40 080101294

    Patients

    Seq Age Sex Outcome Treatment
    1