BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 360

    MDR report key: 4017185 · Received August 11, 2014

    Report

    Report Number
    1124841-2014-00120
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO CORP HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVAL; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT AFTER AUTOCLAVING THE HERCULES 360, THE SLEEVE PINS DROPPED OUT OF THE DEVICE. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475926 HERCULES 360 UNIVERSAL STABILIZER ARM GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. 001-401-160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK