BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 3162423 · Received June 6, 2013

    Report

    Report Number
    1828100-2013-00593
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 16, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED. THE STERNAL SAW WAS RECEIVED BY THE MFR AND TESTED. THERE WAS NO FUNCTIONAL DEFECTS FOUND AND SAW WAS SENT TO SERVICE FOR MAINTENANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-CARDIOPULMONARY BYPASS OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE STERNAL SAW WORKED INTERMITTENTLY. THE DEVICE WAS NOT CHANGED OUT, AS THE CUSTOMER FINISHED THE CASE WITH THE SUSPECT SAW. 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
    251692 TERUMO STERNAL SAW II GFA TERUMO CARDIOVASCULAR SYSTEMS CORP. 5590

    Patients

    Seq Age Sex Outcome Treatment
    1