BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 2961570 · Received February 11, 2013

    Report

    Report Number
    1828100-2013-00163
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE AIR HOSE TO THE STERNAL SAW WAS BROKEN. IT DID NOT SOUND LIKE AIR WAS GETTING TO THE SAW. IT IS UNKNOWN IF THE SAW WAS CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59327 TERUMO STERNAL SAW II GFA TERUMO CARDIOVASCULAR SYSTEM CORP 15665

    Patients

    Seq Age Sex Outcome Treatment
    1