BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 2240821 · Received August 16, 2011

    Report

    Report Number
    1828100-2011-02458
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 16, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE STERNAL SAW WOULD NOT HOLD THE BLADES. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE USER REPORTED THAT SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO STERNAL SAW II FLEXIBLE DRIVE CABLE GFA TERUMO CARDIOVASCULAR SYSTEM CORP. 5590

    Patients

    Seq Age Sex Outcome Treatment
    1