BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSIVE PLANAR BLUNT PROBE

    MDR report key: 4792342 · Received May 22, 2015

    Report

    Report Number
    1723170-2015-00635
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 29, 2015
    Report Date
    November 9, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K972398
    Removal / Correction Number
    1723170-5/4/2015-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. REPLACEMENT DEVICE SHIPPED TO SITE ON (B)(4) 2015 FOR ISSUE RESOLUTION. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT THE BLUNT TIP PROBE HAS BEEN ASSEMBLED WITH A SHARP TIP. THE REPORTED ISSUE WAS CONFIRMED DURING TESTING. THIS ISSUE IS TRENDED AND MONITORED IN A MEDTRONIC HARDWARE ANOMALY TRACKING DATABASE. AN INVESTIGATION INTO THE REPORTED LOT NUMBER FOUND ONE ADDITIONAL COMPLAINT REGARDING THIS ISSUE, REPORTED IN MDR 1723170-2015-00634. IN BOTH MDRS, THE ISSUE WAS IDENTIFIED PRIOR TO CLINICAL USE. FURTHER INVESTIGATION INTO THIS ISSUE WAS COMPLETED BY HARDWARE AND SUPPLIER QUALITY ENGINEERING AND DETERMINED ONE LOT OF PASSIVE PLANAR BLUNT PARTS (LOT 150223) WAS ASSEMBLED INCORRECTLY AT THE SUPPLIER. THE INSTRUMENT END WAS A PASSIVE PLANAR SHARP PROBE AND THE HANDLE END WAS LABELED WITH THE PART NUMBER FOR A PASSIVE PLANAR BLUNT PROBE. THE SUPPLIER CONFIRMED THAT THE ISSUE WAS LIMITED TO LOT 150223 AND THAT (B)(4) PARTS WERE AFFECTED IN TOTAL. OF THE (B)(4) WERE CAPTURED WITHIN MEDTRONIC'S SUPPLY CHAIN PRIOR TO DELIVERY TO THE CUSTOMER. THE REMAINING (B)(4) DEVICES HAVE BEEN, OR ARE IN THE PROCESS OF BEING, RETRIEVED FROM THE CUSTOMER. ON 05/05/2015, A VOLUNTARY CORRECTIVE ACTION NOTIFICATION WAS PROVIDED TO THE AFFECTED SITES TO REPLACE AND REMOVE THE AFFECTED PROBE INSTRUMENTS. THE FIELD ACTION INCLUDES A REVIEW OF CUSTOMER INVENTORY, QUARANTINE AND RETURN OF ANY AFFECTED UNITS STILL IN THE FIELD.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT TWO PROBE INSTRUMENT TIPS HAD SHARP TIPS INSTEAD OF THE EXPECTED BLUNT TIPS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336128 PASSIVE PLANAR BLUNT PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 150223

    Patients

    Seq Age Sex Outcome Treatment
    1