BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY GUIDE

    MDR report key: 2033587 · Received February 11, 2011

    Report

    Report Number
    1723170-2011-00112
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED FOR REPLACEMENT. THE DEVICE IS SINGLE USE AND WILL NOT BE RETURNED. WHILE NO PATIENT HARM WAS ALLEGED, THIS ISSUE IS BEING REPORTED BECAUSE A BIOPSY GUIDE THAT WILL NOT LOCK COULD MOVE DURING SURGERY WITHOUT THE SURGEON NOTICING, WHICH COULD RESULT IN INACCURATE NAVIGATION.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED A BIOPSY GUIDE THAT WOULD NOT LOCK DOWN. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSY GUIDE STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 200501063999

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE