BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL PROBE TAP DRIVER

    MDR report key: 2058723 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00417
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER RMA A REPLACEMENT RMA DRIVER WAS SENT TO SITE FOR REPLACEMENT. UPON EVALUATION OF RETURNED INSTRUMENT, THE DRIVER HAS SEIZED UP. OTHERWISE IT RECEIVES TOOLS AND HANDLE WITHOUT ISSUE.

    Description of Event or Problem · 1

    SITE CALLED TO REPORT THE AWL PROBE TAB DRIVER HAS SEIZED UP. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AWL PROBE TAP DRIVER STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 168387

    Patients

    Seq Age Sex Outcome Treatment
    1