BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 1852097 · Received September 28, 2010

    Report

    Report Number
    1828100-2010-01562
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 28, 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 USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER OBSERVED CRACKS ON THE OUTER CASING OF THE CABLE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THIS EVENT OCCURRED DURING NON CLINICAL ACTIVITY, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO STERNAL SAW II FLEXIBLE DRIVE CABLE GFA TERUMO CARDIOVASCULAR SYSTEMS CORP. 15665

    Patients

    Seq Age Sex Outcome Treatment
    1