BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROVOX VOICE PROSTHESIS

    MDR report key: 2803292 · Received March 4, 2009

    Report

    Report Number
    8032044-2009-00004
    Event Type
    Other
    Date Received
    March 4, 2009
    Date of Event
    January 16, 2009
    Report Date
    February 24, 2009
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    EWL
    PMA / PMN Number
    K940638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION HAS SHOWN THAT THE SECURITY STRAP OF THE PROSTHESIS WAS TORN OFF CLOSE TO THE TRACHEAL FLANGE. NO SIGNS OF AIR BUBBLES OR CUTS WERE FOUND IN THE RUPTURE AREA, WHICH COULD CAUSE A DECREASED TENSILE STRENGTH. NO PRODUCT FAULT COULD BE DETECTED. THIS KIND OF PROBLEM MAY HAPPEN IF THERE IS SOME KIND OF MAJOR OBSTRUCTION IN THE ESOPHAGUS. IN THAT CASE WE RECOMMEND, ACCORDING TO THE MANUAL, TO DILATE BEFORE INSERTION. ANOTHER POSSIBLE REASON IS THAT THE CLINICIAN TRIES TO PULL THE PROSTHESIS THROUGH THE FISTULA, ONLY USING THE SECURITY STRAP AND GUIDE WIRE, INSTEAD OF USING A NON TOOTHED HEMOSTAT FOR THE PLACEMENT AS STATED IN THE MANUAL. TO CONCLUDE, IT SEEMS THAT A TOO BIG FORCE ON THE SECURITY STRAP HAS BEEN USED CAUSING THE RUPTURE. NO PRODUCT FAULT CAN BE DETECTED. WE HAVE TRIED TO OBTAIN INFORMATION ON WHY THE SURGEON DECIDED NOT TO PUT IN A NEW PROSTHESIS INSTEAD OF SUTURING THE FISTULA, BUT HAVE NOT BEEN SUCCESSFUL. THE REASON FOR THIS IS STILL UNCLEAR. ACCORDING TO THE COMPLAINT REPORT THE PATIENT WAS UNAFFECTED AFTERWARDS.

    Description of Event or Problem · 1

    THE SECURITY STRAP BROKE DURING THE RETROGRADE INSERTION OF THE VOICE PROSTHESIS INTO THE FISTULA. ACCORDING TO THE COMPLAINT THE ENT SURGEON STATES THAT HE DIDN'T PULL OUT STRONGLY USING THE GUIDE-WIRE, AND DIDN'T USE ANY LUBRICANT THAT MAY CAUSE THE SECURITY STRAP TO BREAK. FOR REASONS UNKNOWN, THE SURGEON DECIDED NOT TO PUT IN A ANOTHER PROSTHESIS, WHICH WOULD BE THE FIRST HAND CHOICE AND INSTEAD SUTURED THE FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVOX VOICE PROSTHESIS VOICE PROSTHESIS EWL ATOS MEDICAL AB PROVOX 0807018

    Patients

    Seq Age Sex Outcome Treatment
    1 Other