BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3

    MDR report key: 4148074 · Received October 2, 2014

    Report

    Report Number
    1124841-2014-00158
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    October 31, 2013
    Report Date
    September 3, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    MWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AFTER RETROSPECTIVE REVIEW OF COMPLAINT HISTORY OF THE ENDOSCOPIC TECHNOLOGIES, INC. COMPLAINTS TRANSFERRED TO TERUMO CARDIOVASCULAR SYSTEMS (LEGAL OWNER OF THE HERCULES PRODUCT SINCE (B)(6) 3013) TERUMO HAS DETERMINED THAT DURING ANOTHER NON-CLINICAL ACTIVITY, THE HERCULES 3 CABLE ARM BROKE. NO PATIENT INVOLVEMENT. THE INVESTIGATION AND CUSTOMER COMMUNICATION WERE COMPLETED BY ENDOSCOPIC TECHNOLOGIES, INC.; HOWEVER, TERUMO CONSIDERS A CABLE BREAK AT ANY TIME DURING USE TO BE A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615495 HERCULES 3 MWS TERUMO CARDIOVASCULAR SYSTEMS CORP. 001-401-161 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK