BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW

    MDR report key: 1032167 · Received April 21, 2008

    Report

    Report Number
    1828100-2008-00228
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 21, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWH
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING USE IN A CARDIOPULMONARY BYPASS PROCEDURE, THE STERNAL SAW WAS NOISY AND DID NOT CUT AS EXPECTED. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO STERNAL SAW STERNUM SAW DWH TERUMO CARDIOVASCULAR SYSTEMS CORP. 6090

    Patients

    Seq Age Sex Outcome Treatment
    1