BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSIVE BIOPSY NEEDLE

    MDR report key: 4107566 · Received September 22, 2014

    Report

    Report Number
    1723170-2014-01005
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENDOR DETERMINED THAT THE CURRENT MOLD SET UP ALLOWED FOR A PASSIVE BIOPSY NEEDLE ASSEMBLY TO BE IMPROPERLY ORIENTED. THE VENDOR HAS MODIFIED THE SENSOR SET UP IN THE MOLDING MACHINE TO ONLY ALLOW PARTS TO BE SEATED IN THE PROPER ORIENTATION. THIS ISSUE WILL BE TRENDED AND MONITORED IN A MEDTRONIC HARDWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER NOT MADE AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED NO SAMPLE WAS TAKEN WITH THE FIRST NEEDLE, THE SURGEON OBTAINED THE DESIRED BIOPSY USING THE SECOND BIOPSY NEEDLE. RMA ISSUED. REPLACEMENT BIOPSY NEEDLE SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT BIOPSY NEEDLE, PASSIVE, VERIFIED THE REPORTED ISSUE WITH THE ALIGNMENT OF THE CUT WINDOW TO THE INDICATOR ON THE OVERMOLD HUB. THE INNER CANNULA IS NOT ALIGNED WITH THE OVERMOLD.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE, THE SURGEON IDENTIFIED A BIOPSY NEEDLE THAT WAS BAD AT INSTALL. THE CUT WINDOW PLASTIC INDICATOR WAS IN AN INCORRECT POSITION IN RELATION TO THE CUT WINDOW. AN ALTERNATE BIOPSY NEEDLE WAS USED TO CONTINUE AND THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586980 PASSIVE BIOPSY NEEDLE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 066536513

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR