BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 4307561 · Received November 25, 2014

    Report

    Report Number
    1828100-2014-01065
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Date of Event
    October 6, 2014
    Report Date
    November 14, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO MDR 1828100-2014-000903 AND 1828100-2014-01023. THE REPORTED COMPLAINT WAS CONFIRMED BY THE SERVICE REPAIR TECHNICIAN (SRT). THE SRT OBSERVED THE INNER CORE CABLE TO EXTEND AND OUTER CASING TO BE BIND, RESULTING IN THE CABLE BEING NOISY. THE SRT REPLACED BOTH THE INNER CORE AND OUTER CASING. HE PERFORMED A RELEASE TEST ON THE STERNAL SAW AND FLEXIBLE DRIVE CABLE. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. IF ADDITIONAL INFORMATION 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 THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE STERNAL SAW WAS NOISY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766474 TERUMO STERNAL SAW II STERNAL SAW II GFA TERUMO CARDIOVASCULAR SYSTEMS CORP. 15665

    Patients

    Seq Age Sex Outcome Treatment
    1