BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC SYSTEMS FOOT CONTROL WITH DIRECTION

    MDR report key: 3042882 · Received April 4, 2013

    Report

    Report Number
    1045834-2013-01359
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND THE CORD DAMAGED WAS APPROXIMATELY 3 INCHES FROM THE FOOT PEDAL CONNECTION. EVIDENCE SUGGESTS THIS WAS DUE TO MISHANDLING / INCIDENT AT THE CUSTOMER SITE (DAMAGE BY CART). THE EVENT WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE HAD A "DAMAGE CORD" DUE TO BEING RUN OVER BY A CART. THE DEVICE WAS NOT USED IN A SURGERY. THERE WERE NO INJURIES REPORTED NOR MEDICAL INTERVENTION REQUIRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138159 ELECTRIC SYSTEMS FOOT CONTROL WITH DIRECTION HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1