BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY GUIDE

    MDR report key: 3021830 · Received March 26, 2013

    Report

    Report Number
    1723170-2013-00238
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTRARY TO WHAT WAS INITIALLY REPORTED, A REPLACEMENT BIOPSY GUIDE HAS NOT BEEN SENT TO THE SITE. THE CUSTOMER DECIDED THEY WANTED TO REPAIR THE DEVICE ON THEIR OWN INSTEAD OF PURCHASE A REPLACEMENT. NO FURTHER SUBSEQUENT ISSUE HAVE BEEN REPORTED. SUSPECT PART NOT RETURNED TO MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. THE SUSPECT DEVICE LOT NUMBER AND MANUFACTURE DATE IS DEPENDENT ON THE RETURN OF DEVICE TO MANUFACTURER. REPLACEMENT BIOPSY GUIDE SHIPPED TO THE SITE. RETURN OF SUSPECT DEVICE TO MANUFACTURER FOR INVESTIGATION IS NOT EXPECTED, HOWEVER, HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED A PRECISION AIMING DEVICE THAT WAS DAMAGED. THE SCREW THREAD OF THE BIOPSY GUIDE IS DAMAGED AND UNUSABLE. NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124361 BIOPSY GUIDE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1