BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 360

    MDR report key: 4451400 · Received January 22, 2015

    Report

    Report Number
    1124841-2015-00017
    Event Type
    Malfunction
    Date Received
    January 22, 2015
    Date of Event
    December 10, 2014
    Report Date
    January 2, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    MWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    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). CONCLUSION NOT YET AVAILABLE. EVAL IN PROGRESS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT THE HERCULES 360 ARM WAS UNABLE TO LOCK ON TO THE RETRACTOR DUE TO THE RETRACTOR CLAMP HANDLE MOVING FREELY. IT IS UNK WHEN THE EVENT OCCURRED. NO KNOWN IMPACT OR CONSEQUENCES TO THE PT. PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50902 HERCULES 360 UNIVERSAL STABILIZER ARM MWS TERUMO CARDIOVASCULAR SYSTEMS CORP. 001-401-160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK