BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY GUIDE

    MDR report key: 2625446 · Received June 20, 2012

    Report

    Report Number
    1723170-2012-00320
    Event Type
    Malfunction
    Date Received
    June 20, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 24, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO AS NO PT WAS INVOLVED IN THIS CONCERN. LOT NUMBER NOT AVAILABLE AT TIME OF THIS REPORT. DEVICE MANUFACTURE DATE IS DEPENDENT ON THE LOT NUMBER AND NOT AVAILABLE AT THIS TIME. RMA ISSUED. REPLACEMENT PART SHIPPED 5/25/2012. DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVAL.

    Description of Event or Problem · 1

    MEDTRONIC REPRESENTATIVE REPORTED THAT THE CLAMPING FORCE IS WEAK ON THE SITE'S BIOPSY GUIDE AND CANNOT BE FIXED. THERE WAS NO PT PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1