BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 1935833 · Received December 3, 2010

    Report

    Report Number
    1828100-2010-02359
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    December 3, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT AFTER PLUGGING IN THE STERNAL SAW, THE DEVICE FAILED TO FUNCTION. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1