BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 1940718 · Received December 17, 2010

    Report

    Report Number
    1828100-2010-02568
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 17, 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

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    THE USER REPORTED THE CABLE DID NOT FUNCTION AS EXPECTED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO A PATIENT 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