BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENT INSTRUMENT

    MDR report key: 963151 · Received December 10, 2007

    Report

    Report Number
    1418479-2007-00043
    Event Type
    Malfunction
    Date Received
    December 10, 2007
    Report Date
    December 10, 2007
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    KTF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/31/07, RWMIC SALES REPRESENTATIVE INFORMED RWMIC AS INDICATED. THERE WAS INSUFFICIENT INFORMATION AT THIS TIME. ON 11/06/07, COMMUNICATION WITH ENDUSER DID NOT PROVIDE ANY INFORMATION. USER FACILITY WILL NOT COMMUNICATE DIRECTLY. ON 11/12/07, RWMIC REQUESTED INFORMATION FROM THE ENDUSER VIA LETTER, AND AS OF CURRENT DATE, THERE HAS BEEN NO INFORMATION PROVIDED. ON 12/06/07, RWMIC REQUESTED THAT ENDUSER VERIFY VIA EMAIL RECEIPT OF THE LETTER. SHOULD THE DEVICE BECOME AVAILABLE FOR EVALUATION, WE WILL FOLLOW-UP WITH ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BACK BITER ENT INSTRUMENT BROKE DURING A PROCEDURE AND ANOTHER PROCEDURE WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENT INSTRUMENT ENT INSTRUMENT KTF RICHARD WOLF MEDICAL INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 YR