BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVOX2 VOICE PROSTHESIS

    MDR report key: 991414 · Received February 4, 2008

    Report

    Report Number
    8032044-2008-00001
    Event Type
    Malfunction
    Date Received
    February 4, 2008
    Date of Event
    December 18, 2007
    Report Date
    January 21, 2008
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    EWL
    PMA / PMN Number
    K971244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE PREVIOUSLY RECEIVED AND REPORTED COMPLAINTS WHERE THE VOICE PROSTHESIS HAS BEEN INSERTED INTO THE LOADING TUBE WITH THE ESOPHAGEAL FLANGE IN A BACK FOLDED POSITION, WHICH HAS LEAD TO A SIGNIFICANT INCREASE IN INSERTION FORCE BEING APPLIED TO THE BLUE VALVE SEAT. THIS HAS IN SOME CASES LEAD TO A SIGNIFICANT INCREASE IN INSERTION FORCE BEING APPLIED TO THE BLUE VALVE SEAT. THIS HAS IN SOME CASES LEAD TO THAT THE BLUE VALVE SEAT HAS DETACHED FROM THE VOICE PROSTHESES. INVESTIGATION OF THIS COMPLAINT SHOWS THE SAME TYPE OF MALFUNCTION. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED AND REPORTED IN CONNECTION WITH FOLLOW-UP REPORT REGARDING F.EX. MFR REPORT# 8032044-2007-00004 DATED 06/28/2007. MARKET SURVEILLANCE SHOWS THAT THE CORRECTIVE ACTIONS HAVE BEEN EFFECTIVE. THE ABOVE EVENT IS WITHIN THE LIMITS CONCLUDED IN THE FOLLOW-UP REPORT TO #8032044-2007-00004. NO FURTHER ACTIONS ARE DEEMED TO BE NECESSARY. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    BLUE RING (THE VALVE SEAT) WAS PUSHED OUT OF THE PROSTHESIS WHEN BEING INSERTED INTO THE LOADING TUBE DURING PREPARATION OF THE DEVICE. NO EFFECT ON PT SINCE THE VALVE SEAT DISLODGED DURING PREPARATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVOX2 VOICE PROSTHESIS VOICE PROSTHESIS EWL ATOS MEDICAL AB PROVOX2 0704069

    Patients

    Seq Age Sex Outcome Treatment
    1