BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 8684966 · Received June 10, 2019

    Report

    Report Number
    1723170-2019-03132
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    April 16, 2019
    Report Date
    June 10, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. NO PROCODE, COMMON DEVICE NAME AND/OR 510K PROVIDED AS THIS DEVICE IS NOT RELEASED FOR DISTRIBUTION IN THE UNITED STATES. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733823, SERIAL/LOT #: (B)(4), UBD: 01-JAN-2050. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SYSTEM PERFORMED AS INTENDED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE CABLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT AS REPORTED, THE 5H PIN IS BENT ON THE ODU-MAC CONNECTOR. A CONTINUITY TEST ALSO FOUND OPENS FROM PIN 16 OF THE FISCHER CONNECTOR TO PIN 3D OF THE ODU-MAC CONNECTOR, FROM PIN 17 OF THE FISCHER CONNECTOR TO PIN 3K OF THE ODU-MAC CONNECTOR, AND FROM PIN 20 OF THE FISCHER CONNECTOR TO PIN 4C OF THE ODU-MAC CONNECTOR. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO PHYSICAL DAMAGE. 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 DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT WHEN CONNECTING TO THE ZEISS SIDE, THE PIN OF THE CONNECTOR WAS BENT. THE UPCOMING PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES USING ANOTHER CABLE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475172 STEALTHSTATION S7 SYSTEM HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1