BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 360

    MDR report key: 4001163 · Received July 8, 2014

    Report

    Report Number
    1124841-2014-00102
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    June 20, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    MWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE 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, PRIOR TO SURGERY, THE SLEEVE PINS FROM THE HERCULES 360 ARM "DROPPED OFF" THE DEVICE. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398599 HERCULES 360 UNIVERSAL STABILIZER ARM MWS TERUMO CARDIOVASCULAR SYSTEMS CORP. 001-401-1600 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK