BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 1841871 · Received September 20, 2010

    Report

    Report Number
    1828100-2010-01497
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 20, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 DEVICE WOULD NOT POWER ON. THE USER REPORTED THE CABLE WAS REPLACED. UPON RECEIVING THE DEVICE FOR EVAL, IT WAS REPORTED THAT THE OUTER SHEATH OF THE CABLE WAS CUT AND APPEARED NOT TO BE A CABLE SUPPLIED BY TERUMO. AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. 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