BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 PREMIUM SYSTEM

    MDR report key: 9261059 · Received October 31, 2019

    Report

    Report Number
    1723170-2019-05418
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    August 28, 2019
    Report Date
    October 31, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733823, SERIAL/LOT #: (B)(4); PRODUCT ID: 9733823, SERIAL/LOT #: (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SCOPE WOULD NOT CONNECT. THE CABLE WAS REPLACED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE CABLE 9733823 ZEISS COMBINED (LOT# 141113) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND THAT THE RETURNED CABLE WAS IN GOOD CONDITION AND PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. NO PROBLEM WAS FOUND. THE CABLE 9733823 ZEISS COMBINED (LOT# 130808) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND THAT BOTH J1 AND J2 CABLES WERE BURNT OR MELTED NEAR THE CONNECTOR. THEY HAD BEEN COVERED WITH SHRINK TUBING. A CONTINUITY TEST FOUND OPENS FROM PIN 3E OF THE ODU-MAC CONNECTOR TO PIN 2 OF THE J1 CONNECTOR, PIN 3B OF THE ODU-MAC CONNECTOR TO PIN 3 OF THE J1 CONNECTOR, AND PIN 3H OF THE ODU-MAC CONNECTOR TO PIN 4 OF THE J1 CONNECTOR. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE MICROSCOPE INTEGRATION CABLES WERE DAMAGED. THE SITE HAD TWO OF THEM THAT WOULDN'T CONNECT. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055961 STEALTHSTATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1