BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO STERNAL SAW II

    MDR report key: 3912771 · Received May 14, 2014

    Report

    Report Number
    1828100-2014-00336
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GFA
    PMA / PMN Number
    K935391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) CALLED THE MANUFACTURER, AS HE WANTS TO REPAIR THE DEVICE HIMSELF. NO PART IS AVAILABLE OUTSIDE OF SERVICE, SO AN ESTIMATE WAS PROVIDED TO THE CUSTOMER FOR REPAIR BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY (STERILIZATION), THE BLADE GUARD/ PROTECTOR WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288065 TERUMO STERNAL SAW II GFA TERUMO CARDIOVASCULAR SYSTEMS CORP. 5590

    Patients

    Seq Age Sex Outcome Treatment
    1