BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 3871624 · Received April 16, 2014

    Report

    Report Number
    1828100-2014-00295
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 25, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY (CLEANING), THE SET SCREW WAS STUCK IN THE STERNAL SAW. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233505 TERUMO STERNAL SAW II STERNAL SAW II GFA TERUMO CARDIOVASCULAR SYSTEMS CORP. 5590

    Patients

    Seq Age Sex Outcome Treatment
    1