BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 1881184 · Received October 1, 2010

    Report

    Report Number
    1828100-2010-01579
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 27, 2010
    Report Date
    October 1, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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 A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE CABLE DID NOT PROVIDE POWER FOR THE SAW TO FUNCTION. THE USER REPORTED ATTACHING AN ALTERNATE CABLE TO THE SAW, AND THE SAW FUNCTIONED AS EXPECTED. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO A 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 SYSTEMS CORP. 15665

    Patients

    Seq Age Sex Outcome Treatment
    1