BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVOX2 VOICE PROSTHESIS

    MDR report key: 1497421 · Received September 8, 2009

    Report

    Report Number
    8032044-2009-00003
    Event Type
    Malfunction
    Date Received
    September 8, 2009
    Date of Event
    August 14, 2009
    Report Date
    September 1, 2009
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    EWL
    PMA / PMN Number
    K971244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 HEAT. 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 MALFUNCTION. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED AND REPORTED IN CONNECTION WITH FOLLOW-UP REPORT REGARDING (B)(4) 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. (B)(4).

    Description of Event or Problem · 1

    A REPLACEMENT WAS DONE BY AN (B)(6) SURGEON WITH A PROVOX2 ON (B)(6). AFTER THE REPLACEMENT, UPON CHECKING THE NEW PROSTHESIS, THE (B)(6) SURGEON COULD NOT FIND THE BLUE RING (THE VALVE SEAT) INSIDE THE NEW PROSTHESIS. ACCORDING TO THE ATTENDING NURSE, THE (B)(6) SURGEON SAID THE PROSTHESIS WAS WITH A VALVE SEAT DURING INSERTION AND HE SUSPECTED THAT IT HAD FALLEN OUT DURING INSERTION. THE PT WAS THEN SENT FOR X-RAY TO CHECK THE LOCATION OF THE DETACHED VALVE SEAT AND IT WAS LOCATED IN THE PT'S STOMACH. IT IS EXPECTED TO BE REMOVED BY NORMAL BOWEL MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVOX2 VOICE PROSTHESIS VOICE PROSTHESIS EWL ATOS MEDICAL AB PROVOX2 0612007

    Patients

    Seq Age Sex Outcome Treatment
    1