BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC SYSTEMS FOOT CONTROL

    MDR report key: 3000200 · Received February 14, 2013

    Report

    Report Number
    1045834-2013-00239
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE "BOTTOM ON THE UPPER LEFT SIDE OF THE DEVICE POPPED OFF WITH THE SPRING." THE DEVICE WAS WORKING AND THEN AS THE SURGEON STEPPED ON THE DEVICE, THERE WAS A SNAP AND THE DEVICE STOPPED WORKING. THE DEVICE WAS BEING USED DURING A 'MINIMAL INVASIVE TUBULAR RETRACTION' PROCEDURE. THE PROCEDURE WAS DELAYED FOR ABOUT FIVE MINUTES DUE TO COMMUNICATION AND TRANSFERRING THE DEVICE OUT. THE CASE CONTINUED WITH ANOTHER DEVICE. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64931 ELECTRIC SYSTEMS FOOT CONTROL HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown