BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 2915436 · Received January 9, 2013

    Report

    Report Number
    1828100-2012-01628
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 14, 2012
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR STERNOTOMY IN PREPARATION FOR A CARDIOPULMONARY BYPASS PROCEDURE, THREE STERNAL SAW BLADES WERE ¿JUMPING ALL OVER THE PLACE¿ AND MAKING A JAGGED CUT. THEY CONTINUED TO USE THE DEVICE AND BLADES. THE STERNAL SAW WAS NOT CHANGED OUT. THE SURGICAL PROCEDURES WERE 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
    13181 TERUMO STERNAL SAW II GFA TERUMO CARDIOVASCULAR SYSTEMS CORP. 5756

    Patients

    Seq Age Sex Outcome Treatment
    1