BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 4122501 · Received September 22, 2014

    Report

    Report Number
    1828100-2014-00832
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    June 19, 2014
    Report Date
    September 11, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED BY THE SERVICE REPAIR TECH (SRT). THE HAND PIECE WAS OPERATED WITH A SERVICE DRIVE CABLE. THE DEVICE OPERATED TO SPECIFICATION AND WAS NOT NOISY. THE NOISE WAS ISOLATED TO THE FLEXIBLE DRIVE CABLE. IT WAS ORIGINALLY REPORTED BY THE FACILITY THAT THERE WERE NO FUNCTIONAL ISSUES, BUT THE DRIVE CABLE LACKED LUBRICATION AND HAD A BEND NEAR THE MOTOR CONNECTOR. THIS BEND CAUSED BINDING DURING TESTING OF ITS OPERATION. THE DRIVE CABLE CASING AND CORE WERE REPLACED BY THE SRT. THE UNIT OPERATED TO MFR SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. IF ADDITIONAL INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS A GRINDING NOISE IN THE STERNAL SAW, BUT THE SAW STILL FUNCTIONED. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587798 TERUMO STERNAL SAW II GFA TERUMO CARDIOVASCULAR SYSTEMS CORP. 5590

    Patients

    Seq Age Sex Outcome Treatment
    1