BEUDAMED
    FDA Adverse Event Other Summary report: N

    9710055-2008-00019

    MDR report key: 1311633 · Received December 18, 2008

    Report

    Report Number
    9710055-2008-00019
    Event Type
    Other
    Date Received
    December 18, 2008
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZABLE HANDLES BECOME DAMAGED AFTER MULTIPLE REUSE AND STERILIZABLE PROCESSES. THE STERILIZABLE HANDLE CONDITION IS TO BE CONTROLLED BEFORE USE BY THE MEDICAL STAFF AS DESCRIBED IN THE USER MANUAL. THE BROKEN PART HAS BEEN REPLACED AT THE CUSTOMER SITE. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET SA PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FSY

    Patients

    Seq Age Sex Outcome Treatment
    1