BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 4865052 · Received June 22, 2015

    Report

    Report Number
    1828100-2015-00500
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 1, 2015
    Report Date
    August 3, 2015
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED. THE SERVICE REPAIR TECHNICIAN (SRT) OBSERVED THE STERNAL SAW BLADE PROTECTOR WAS BENT. THE SRT PERFORMED A FUNCTIONAL TEST AND OBSERVED THE SAW TO OPERATE AS INTENDED WITHOUT THE SAW BLADE. THE SRT PERFORMED INTERNAL INSPECTION AND OBSERVED THE STERNAL SAW TO BE CLEAN AND FREE OF CORROSION. THE SRT REPLACED THE SAW BLADE PROTECTOR AND PERFORMED VERIFICATION/RELEASE TESTING. THE STERNAL SAW OPERATED TO MANUFACTURER SPECIFICATIONS AND WILL BE RETURNED TO THE CUSTOMER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE OPEN HEART TEAM GAVE THE STERNAL SAW TO THE STERILIZATION TEAM, WHO THEN NOTIFIED CENTRAL STERILIZATION (C/S) TECHNICIAN OF THE BENT BLADE PROTECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-CARDIOPULMONARY BYPASS, THE BLADE PROTECTOR WAS BENT ON THE STERNAL SAW. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404087 TERUMO STERNAL SAW II STERNAL SAW II GFA TERUMO CARDIOVASCULAR SYSTEMS CORP. 5590

    Patients

    Seq Age Sex Outcome Treatment
    1