BEUDAMED
    FDA Adverse Event Other Summary report: N

    8010652-2008-00003

    MDR report key: 1015226 · Received February 15, 2008

    Report

    Report Number
    8010652-2008-00003
    Event Type
    Other
    Date Received
    February 15, 2008
    Product Code
    FWZ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    SHORTLY, AFTER THE INCIDENT OCCURRED, A SURGICAL PRODUCT SPECIALIST VISITED THE HOSP AND CAPTURED IMAGES OF THE PELVIC EXTENSION ACCESSORY. THESE IMAGES WERE RELAYED TO THE MFR'S SUPPORT TEAM AND IT WAS DETERMINED THAT THE DIMENSIONS OF THE PELVIC ACCESSORIES' SIDE RAILS WERE DIFFERENT THAN THE STANDARD U.S. PRODUCT. THESE DIMENSIONS WERE CONSISTENT WITH FOREIGN MODELS OF THE SURGICAL TABLE. A REPLACEMENT PELVIC EXTENSION ACCESSORY WAS DISPATCHED TO THE HOSP THE NEXT DAY AND THE ACCESSORY WITH THE FOREIGN SIDE RAILS WAS RETURNED TO THE MFR. GETINGE USA, INC SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANANLYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1