BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE HANDLE

    MDR report key: 5058880 · Received September 4, 2015

    Report

    Report Number
    2015691-2015-02326
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 6, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    GDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HAS NOT BEEN RETURN FOR EVALUATION. THIS IS NOT A SERIALIZED DEVICE, THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE DONE. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER, IT WAS LEARNED THIS DEVICE HAD BEEN IN SERVICE FOR SOME TIME AND MAY HAVE BROKEN DUE TO WEAR AND TEAR. IT IS UNKNOWN HOW LONG THIS DEVICE HAS BEEN IN SERVICE AND HOW MANY CLEANING AND STERILIZATION SESSIONS IT HAS BEEN THROUGH. THIS IS A UNIVERSAL HANDLE. ALL OF THE CURRENT STOCK HAS BEEN REPLACED WITH NEW PRODUCT AS IT IS NOT POSSIBLE TO DETERMINE THE AGE AND MAINTENANCE HISTORY FOR EACH DEVICE. THE DEVICE IS ANTICIPATED TO BE RETURNED FOR EVALUATION. IF NEW INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EDWARDS LEARNED THROUGH A FOLLOW UP MEETING WITH THE CUSTOMER THAT A UNIVERSAL HANDLE REPORTEDLY BROKE IN TWO PIECES AS THE DOCTOR WAS TIGHTENING IT. [THE HANDLE BROKE WHILE THE SURGEON WAS TRYING TO POSITION AN AORTIC VALVE DEVICE FOR REPLACEMENT.] THE DOCTOR PROCEEDED WITH THE CASE BY REPLACING THE HANDLE. ALL BROKEN PIECES WERE ACCOUNTED FOR PER THE DOCTOR. BROKEN HANDLE WILL BE RETURNED FOR EVALUATION. NO PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587678 REUSABLE HANDLE GDZ EDWARDS LIFESCIENCES 1111

    Patients

    Seq Age Sex Outcome Treatment
    1