BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 3130120 · Received May 21, 2013

    Report

    Report Number
    1828100-2013-00496
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE BLADE PROTECTOR WAS BENT ON THE STERNAL SAW. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225269 TERUMO STERNAL SAW II GFA TERUMO CARDIOVASCULAR SYSTEMS CORP 5590

    Patients

    Seq Age Sex Outcome Treatment
    1